36 Risk based classification list of Class A(non-sterile and non-measuring) medical device 2025-Oct-31 1069 KB

Appendix A

F. No. MED-16014(12)/1/2024-eoffice-Part(2)

Risk classification list of Class A (non-sterile and non-measuring) medical devices Note to Stakeholders:

1. All Class A (non-sterile and non-measuring) medical devices are exempt from the provisions of Chapter IV, V, VII, VIII and XI of the Medical Devices Rules, 2017, subject to the condition that the manufacturer/importer shall make registration of such devices, under the provisions of Chapter IIIB of these rules. S. No. Device Name Intended Use
   1 Abdominal scissors, reusable A hand-held surgical instrument intended to cut the abdominal tissue, in particular the abdominal wall tissue, during surgery. This is a transient- use, reusable device intended to be sterilized prior to use. 2 Abdominal support/belt/binders, reusable Intended to hold abdominal muscles together to relieve pain and increase circulation at surgical site to promote healing and decrease swelling. May also make physical activity more comfortable. 3 Abdominal support/belt/binders, single use A non-sterile, disposable device Intended to hold abdominal muscles together to relieve pain and increase circulation at surgical site to promote healing and decrease swelling. 4 Abdominal/ENT/orthopaedic surgical probe, reusable A hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. This is a reusable device. 5 Abrasive polishing agent A substance, or combination of abrasive substances (e.g. silica pumice), intended to be used for cleaning the accessible surfaces of the teeth by polishing. It does not contain medication and used by dental professionals. 6 Absorbent cotton wool, non- sterile Intended to be used for applying medication to, or absorbing small amounts of body fluids.

7 Absorbent underpad, antimicrobial A flat piece of absorbent fabric material intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures or incontinence. It may include an antibacterial agent [e.g., silver (Ag)] and typically helps to eliminate unwanted odours (not for ancillary therapeutic action). It is intended to be used in the healthcare facility and in the home. 8 Absorbent Underpad, non- antimicrobial A non-sterile absorbent fabric intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence). It may be intended for home-use or/and hospital settings.
9 Accupressure applicator, reusable Applied to the skin without insertion into the body to apply pressure and/or friction to accupressure points. 10 Accupressure applicator, single-use To be used for acupressure treatment at home by applying non-invasive pressure to acupuncture points. Applied to the skin without insertion into the body. 11 Accupressure calf band Intended to be worn around the calf to apply pressure to an accupressure point to relieve low back pain, including sciatica and piriformis syndrome. 12 Accupressure wristband Intended for the application of pressure to the Nei-kuan (P6) acupressure point on the wrist, the area identified to help relieve the sensation of nausea. It does not have measuring function. 13 Acoustic chamber for audiometric testing Intended for use in conducting diagnostic hearing evaluations, while eliminating sound reflections and providing isolation from outside sounds. 14 Acoustic Stethoscope A mechanical listening device used for listening to sounds from the heart and lungs and their qualitative assessment.
15 Adaptor, light source Intended to permit the connection of the devices that together deliver light to a work field from a light source. 16 Adaptor, luer, non-sterile Non-invasive adapters which connect or stopper enteral feeding tubes. 17 Adenotome blade, reusable A blade intended to be mounted into the handle of an adenotome to excise the adenoids during an adenoidectomy. This is a reusable device. 18 Adenotome, reusable to excise pharyngeal tonsils or adenoids during a procedure known as an adenoidectomy. This is a reusable, transient-use device.

19 Adhesive felt pad Intended to offload pressure from ulcer areas, recurrent plantar ulcers, calluses and corns. 20 Adhesive pad for Transcutaneous electrical stimulation electrode
Reusable gel pads that allow TENS electrodes (not included) to adhere gently to the skin. 21 Adhesive plaster (Zinc oxide adhesive plaster)/Tape It is intended to secure dressings and for strapping on intact skin. 22 Adhesive strip A flexible strip (of fabric, plastic, paper, or other material) coated on one side with a pressure- sensitive adhesive, typically used to cover or approximate the edges of superficial wounds or fix dressings to skin. The device may include an adhesive pad and have qualities such as waterproof.
23 Adhesive tape remover Intended to help reduce pain and ease removal of medical adhesives used in stoma care products, dressings and other medical appliances from the skin surface. 24 Adult Incontinence Pants/Diaper A disposable undergarment (a nappy or diaper) intended to be worn between the legs used to collect urine and faeces from an incontinent adult patient.
25 Aerosol adhesive for compression garments A sticky substance intended to be applied on the skin to anchor compression garments in place. 26 Air cushion/Pressure relief cushions Intended to relieve pressure on an affected area when a person has hemorrhoids or when he has undergone surgery in the back or buttock area/prevention of pressure sores/ulcers in patients. 27 Airway device cleaning utensil A hand-held device intended to be used to clean an in situ airway device (not disinfection). It can also be used to clean an airway device ex situ (i.e., once it has been removed from the patient). 28 Airway tube forceps, reusable Intended for grasping a tube for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways. 29 Alarm, bed occupancy Bed Floor Mat/Crash Mat Alarm/Alert Patient Movement 30 Alcohol swab A non-sterile absorbent swab containing alcohol intended for cleaning and scrubbing of needle access sites. 31 Alignment guide for orthopedic fixation A reusable instrument intended to facilitate the correct orientation (alignment) of an implant during a surgical procedure. This is a non- measuring device intended for transient use. 32 Allergy testing adhesive strip, epicutaneous A band of adhesive material intended to be used for epicutaneous allergy testing.

33 Alternating-pressure bed mattress A mattress-like device intended to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and to connect to a pump (not included) to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores.
34 Alternating-pressure bed mattress overlay, reusable A non-sterile pad or thin mattress, usually full- body length, which is intended to be placed on top of a bed mattress to actively change an occupant's bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores, decubitus ulcers, etc. in elderly immobilized, patients with disabilities, or patients with low body fat. This is a reusable device. 35 Alternating-pressure bed mattress overlay, single-use A non-sterile, disposable pad or thin mattress, usually full-body length, which is intended to be placed on top of a bed mattress to actively change an occupant's bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores, decubitus ulcers, etc. in elderly immobilized, patients with disabilities, or patients with low body fat.
36 Ambulance stretcher loader A battery-powered, hydraulically-operated device designed to be installed within an ambulance to support the loading and unloading of an ambulance stretcher, to improve the safety and ease of patient transfer to and from the ambulance. 37 Ambulance stretcher, electrohydraulic/pneumatic A pneumatic or hydraulically-operated device intended for use by healthcare personnel primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles. Ambulance-mounted locking/docking devices may be included.
38 Ambulance stretcher, manual A manually-operated device intended for use by healthcare personnel primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles. It also usually includes locking devices that match with the locking/docking devices in the ambulance. 39 Amniotic membrane perforator, reusable A manual surgical instrument intended to rupture the amniotic membrane to assist in childbirth, without causing injury to the mother or foetus. This is a reusable device. 40 Amsler grid Intended to rapidly detect central and paracentral irregularities in the visual field.

41 Anaesthesia catheter Luer connector, non-sterile Intended to create a mechanical union between an anaesthesia catheter and an external device. 42 Anaesthesia instrument table It is intended as a support for Anaesthesia instruments used during general anaesthesia surgical procedures. 43 Anaesthesia mask stabilizer A non-sterile, disposable accessory to anesthesia face mask intended to secure an anaesthesia mask on the face of a patient typically by providing anchorage for the fixation of the mask's headstrap. 44 Anaesthesia system leakage tester A device intended to test an anaesthesia system for leakage. This does not have a measuring function. 45 Anaesthesia tube holder, non-sterile The intended purpose for this device is for holding and supporting respiration tubing and breathing circuits connected to a patient, to prevent disconnection. This is a noninvasive device. 46 Analytical non-scalp cutaneous electrode Electrical conductor intended to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device (not included) for electrophysiological recording/monitoring. 47 Analytical non-scalp cutaneous lead Intended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device (not inclulded) designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. 48 Anatomical model for surgical planning A 3-D printed patient specific model of an organ (e.g., heart, kidney, lung) or bone(s) intended to be used to assist peri-operative anatomical visualisation and surgical treatment planning. It is created using 3-D Printing processes based on patient medical images.
49 Aneurysm clip applier, reusable A surgical instrument intended for the application/insertion of aneurysm clips (not included). This is a reusable device. 50 Ankle binder, reusable A strip or roll of fabric or plastic material intended to be wrapped around the ankle to help stabilize and support the joint. 51 Ankle cap Intended to provide mild compression and support to the ankle joint and to manage ankle pain and inflammation. 52 Ankle sleeves/brace Intended as the external supports to limit certain motions, such as plantar flexion/inversion and manage postoperative/posttraumatic pain.

53 Ankle traction belt Intended to immobilize the ankle and adjoining joints after injury/surgery to support fast healing and prevents further damage and also helps to decrease pain, spasms and swelling. 54 Ankle/foot orthosis A prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. 55 Anomaloscope Intended to test a patient for abnormal red/green colour vision by differentiating the red/green colour vision defects. This does not have a measuring function. 56 Anterior chamber physical simulator A non-powered, non-patient-contact device intended to mimic the fluid dynamics in the anterior chamber of the eye during priming/calibration of a phacoemulsification system irrigation/aspiration pump (not included). 57 Anterior wedge footwear/Off loading shoes Intended for offloading the pressure from forefoot to heel after correction of conditions such as Hallux Valgus, Hammer Toes, Tailors Bunions and Ulcers of the forefoot. 58 Antiseptic generation system Intended for generation/synthesis of disinfectant at the point-of-care (onsite) for wound irrigation and management. 59 Anti-shock body support/Garment A non-invasive device intended to prevent excessive blood loss and prevent post partum haemorrhage complications. 60 Anti-tremor gyroscopic orthotic glove A battery-powered device intended to be worn on the hand/forearm of a patient with hand tremors [e.g., due to Parkinson’s disease, Essential tremor (ET)] to reduce tremors, promote hand stabilization, and facilitate activities of daily living using the hand.
61 Arm board pad It is intended to provide support to the patient's arm during prolonged surgeries.
62 Arm board, pediatric It is intended to immobilize and hold steady infants’ limbs when securing intravenous lines. 63 Arm sling Intended to immobilize the arm, by means of a fabric band suspended from around the neck. 64 Arm/leg procedure positioner padded strap Intended to protect the patient's foot/leg in stirrups during surgical interventions. 65 Artificial airway stylet, reusable A device intended for insertion within the lumen of an artificial airway tube to stiffen and/or maintain the shape of the tube to facilitate intubation. It is withdrawn after intubation has been completed. This is a reusable device.

66 Artificial airway washing/disinfection jar A container intended to hold artificial airway devices to facilitate their washing/disinfection. This is a reusable device and does not include disinfectants. 67 Assistive coverall A lightweight wrap specially designed/adapted to be used by a person with a disability to cover and protect them against precipitation (rain, snow, sleet), cold and wind, especially when using a wheelchair, pram, or sledge. 68 Assistive ergonomic chair An electrically- or manually-adjusted device intended to support and position a disabled/elderly/bariatric patient in a sitting posture while performing activities of daily living, including work-related activities and to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair component. 69 Assistive ergonomic chair mobility base Intended for use as a support to an assistive ergonomic chair used by a healthcare provider/carer to provide mobility for a disabled (often paediatric) patient. 70 Assistive foot-propelled bicycle A specially-designed vehicle intended to be used by persons with disability to provide them a means of transportation, typically without the attendance of another person.
71 Assistive gripping/twisting tool, reusable A handgrip intended for stimulation of the sensory neuronal network (hand/fingers) as part of therapies for patients suffering from neurodeneration such as ASD, ADHD and Parkinson's, or other nervous issues. 72 Assistive mobility device, powered A powered device (e.g., moped) specifically designed and intended to provide mobility to a disabled person. 73 Assistive patient lifting pole A device designed as an overhead bar with a hanging handgrip above the patient that is attached to a medical bed or secured to the wall behind the bed and intended for use by the patient (with limited mobility/weakness) to provide support when changing position or pulling themselves into a sitting position. 74 Assistive shoes/boots It is a shoe attachment that is primarily intended to assist people with Parkinson’s to overcome a symptom called Freezing of Gait (FOG) through visual cueing by providing visual cues in the form of laser lines. It can act as an intervention for falls prevention in the Parkinson’s population.

75 Atomizer, non-ventilatory A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. This does not have a measuring function (non-graduated). 76 Autopsy saw with/without vacuum filtration unit intended to be used during autopsies on cadavers for bone cutting. It may have a vacuum filtration unit for collection of dry bone dust and debris. 77 Autopsy/dissection table, mechanical/electric A device intended to provide a working surface for the examination and dissection of organs and other anatomic parts mostly during postmortem pathologic investigations and for demonstration purposes. Not for use during surgical/diagnostic procedures on living humans. 78 Back Support/Brace Intended to prevent unnecessary movements and pain that may further damage the back and to help in alignment of spine and strengthening of back muscles. 79 Bagolini lens/Bagolini striated glasses Intended to determine harmonious/anomalous retinal correspondence. 80 Balance Board Intended to train patient with difficulties in balance (proprioreception) ( e.g. a paraplegic or a stroke patient). 81 Bandage scissors, reusable Heavy scissors for cutting pads, plaster and plastic rail associations. 82 Bariatric table/bed Intended to accommodate and support a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys. This does not have any other therapeutic/measuring or diagnostic function. This may be electrically adjusted.
83 Basket stretcher
Intended to transfer patients in emergency situations such as in the mountains, and marine offshore application. 84 Bath towelette A non-sterile, disposable device intended for use in healthcare settings to clean and wipe the skin of patients who are immobile or bedridden due to surgery, injury, paralysis, sepsis, critical illness, etc., or for those with surgical wounds/drains (where water contact needs to be minimized). May also be used on pediatric and immunocompromised patients. 85 Bed board A flat, stiff device intended to increase the firmness of a hospital bed's mattress to provide an appropriate rest surface for the user typically with spinal problems.

86 Bed exit monitor, fall prevention Intended to be placed under mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed. 87 Bed traction frame Intended to provide overhead support framing for hospital beds to assist in the treatment and movement of bed patients. 88 Bedrail pad Intended to protect the patient from coming into contact with the bedrails and inadvertently hurting or injuring themselves. 89 Bedside screen General-purpose, non-sterile, hospital-use device intended to create a partition in order to conceal a patient in a bed or examination table during medical procedures (not intended for maintaining sterile field).
90 Binocular indirect lenses Intended for visualization of the human retina (fundus) using a binocular indirect ophthalmoscope. 91 Binocular loupes It is intended for viewing details of objects with some magnification during ophthalmic/dental and other examinations and surgeries. It does not have a measuring function. 92 Biohazard spill clean-up kit A set of non-sterile devices intended for use in hospital settings to clean up and dispose infectious material (such as blood, urine, vomit, etc.), a mercury (Hg) spillage due to thermometer/device breakage, etc., hazardous chemical spills (such as formalin, etc.), in a safe manner.
93 Birthing bath A non-powered bath intended to be filled with heated water for use before and/or during child birth and to provide a comfortable environment for the expecting mother prior to birth. 94 Birthing bed/table, non- powered A manually-operated, adjustable device intended to support a pregnant woman's body in an appropriate position during labour and delivery, and may in addition be intended for other obstetrical examination or treatment procedures. This device may be referred to as a birthing/obstetric bed, table, couch, or chair. This does not include any diagnostic/therapeutic device or instrument. 95 Birthing bed/table, powered An electrically-powered, adjustable device intended to support a pregnant woman's body in an appropriate position during labour and delivery, and may in addition be intended for other obstetrical examination or treatment procedures. This device may be referred to as a birthing/obstetric bed, table, couch, or chair. This does not include any diagnostic/therapeutic device or instrument.

96 Birthing cushion A device intended to provide positional support and comfort for a pregnant woman during labour and/or childbirth. It may be placed on the floor and might facilitate a variety of birthing positions. 97 Bite block, dental, reusable A non-sterile device intended to be inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) and to allow them to bite down on for greater comfort during a dental procedure. This is a reusable device. 98 Bite block, endoscopy, non- sterile A reusable device intended to be inserted in a patient's mouth to maintain oral patency and protect both the patient and the endoscope (not included), when an endoscope is inserted into a patient's mouth for a procedure. It does not have any additional functionality.
99 Bite block, radiotherapy, non-sterile A reusable device intended to reproducibly position the mouth, tongue or lips during radiotherapy treatment of the head and neck.
100 Bite registration rim wax A dental material (modelling wax) with or without reinforcing foils (metal, polymer) intended for registration of jaw relation (making bite rims).
101 Bite relief pad Intended to help relieve pain or discomfort after orthodontic treatment by placement between the upper and lower sets of teeth and bitten down on. 102 Bladder neck spreader, reusable A manual gastroenterology-urology surgical instrument intended to be used to manually separate and spread the bladder neck. This is a reusable device intended for transient use. 103 Blepharoplasty scissors, reusable A hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty). This is a reusable device. 104 Blood transfusion chair/couch A height-adjustable device intended to position the patient in such a manner that a technician/nurse has easy access to the patient's arm for drawing blood. Blood drawing equipment is not included. 105 Bobath table Intended for postural exercises, rolling, turning and balance training of patients with loss of sensation or poor balance and other neurological conditions such as stroke, head injury and orthopedic indications. 106 Body arch traction table Intended to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch.

107 Body waste receptacle Intended for medical purposes that is not attached to the body and that is used to collect the body waste of a bed patient. 108 Bone curette, reusable A manual surgical instrument intended for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure without causing trauma to the surrounding muscles. This is a reusable device. 109 Bone cutting forceps, reusable A hand-held, surgical instrument intended for cutting posterior rib ends and bone tissue during a surgical procedure. This is a reusable device. 110 Bone distraction forceps, reusable A hand-held, manual, open-surgery instrument intended to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. 111 Bone file/rasp, manual, reusable to scrape and smooth the surface of bone during a surgical procedure; It is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a reusable device.
112 Bone holding forceps, reusable A manual surgical instrument intended to grasp and hold a bone during an open surgical procedure. This is a transient-use, reusable device. 113 Bone hook/ Bone retractor, reusable A hand-held, surgical instrument intended for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. This is a reusable device intended for transient use. 114 Bone nail driver, reusable to impart force on another instrument or directly on a bone fixation nail to insert the nail into tissue (i.e., to drive the nail into the intramedullary canal). This is a reusable device intended for transient use. 115 Bone tap, reusable A manual surgical instrument intended for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). This is a reusable device. 116 Bowl stand Intended to store and hold medical bowls. Intended for hospital use. 117 Box Wrench for Nut/Bolt, reusable A minimally invasive, hand-held manual surgical instrument intended to grip, twist or turn nut and bolt during orthopedic surgery. This is a reusable device. 118 Brachytherapy radionuclide phantom, test object Intended to mimic the functional/physical characteristics of normal or diseased human organs during performance evaluations of brachytherapy system.

119 Breast binder A non-sterile device intended to be applied to the breast or breasts for soft tissue support or securing a dressing in place after surgical procedures. 120 Breast pump support kit, reusable A collection of non-sterile items (e.g., breast shields, tubing, connectors, milk collection containers , etc.) intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. This is a reusable device. 121 Breathing circuit equipment dryer / drying chamber A device that is used for the purpose of drying breathing circuit equipment that have been washed in order to prevent bacteria growth and deterioration. This is not intended for disinfection and does not have a measuring function. 122 Bulldog clamp forceps/ Clamp manipulation forceps, reusable to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. This is a reusable device intended to be sterilized prior to use (transient duration). 123 Cable-controlled external hand prosthesis Intended as an artificial hand for physically disabled persons, whose movement can be controlled by a cable. 124 Camera for medical applications A non-invasive camera intended to be used with microscopes, colposcopes and on endoscopic procedures for recording and capturing of images of internal structures. This does not have any AI- integrated or image analysis functions.
125 Canalith repositioning procedure chair, manual A device intended to be occupied by a patient and manually operated by a healthcare professional to facilitate therapeutic physical manoeuvres of the patient’s head and trunk (accelerations and decelerations in a multiaxial plan) to treat balance disorders [e.g., benign paroxysmal positional vertigo (BPPV), canalithiasis] caused by displaced canaliths (otoconia) in the inner ear of the patient. 126 Capnography sampling adaptor It is a non-sterile device intended to function as an interface between an in situ airway device (e.g., oropharyngeal airway, face mask, nasal oxygen cannula) and respiratory sampling tubing connected to a carbon dioxide monitor (capnograph) . 127 Cardiac compression board A flat, rigid device that is placed under a patient to act as a support during cardiopulmonary resuscitation.

128 Cardiopulmonary resuscitation mask, reusable A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). It is not intended to connect to an active device. The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross- contamination. This is a reusable device. 129 Cardiopulmonary resuscitation mouthpiece/cover A non-sterile device that consists of a mouthpiece with an integrated face/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (CPR) to prevent cross-contamination between patient and CPR administrator. This is a single- use device. 130 Cartilage knife/ Chondrotome, reusable for cutting, shaving or shaping cartilage during a surgical intervention. This is a reusable device. 131 Cast boot/shoes A boot-like cover for a foot enclosed in a leg cast or bulky bandages intended to support postsurgical healing, injury/trauma care or any situation that requires a pressure off-load of the foot.
132 Cast cutter vacuum system An assembly of devices intended to collect the dust produced by a cast cutter (e.g., pneumatic or electric cast saw) from the workspace environment by suction during the cast removal procedure. It is not intended for surgical/on- patient use. 133 Cast cutting scissors A hand-held surgical instrument intended to cut small plaster cast dressings and layers of thick material, e.g., bandages. This is a reusable device. 134 Cast removal protective tape Intended to be placed between a cast stockinette and the lining of a cast, along the line where subsequent cast cutting is intended to occur during cast removal, to prevent cuts and burns to the skin caused by the cast cutter/saw. 135 Cast stockinette Intended to be used with casting material to provide under-cast padding and cushioning. 136 Cast walking heel A rubber device intended to be attached to or incorporated into a cast to support the patient while walking. 137 Cerebral Cavernous Malformations (CAM) vision stimulator Intended for stimulation of the eye for treatment of lazy/ambyopic eye.

138 Cerebral Palsy (CP) walker Intended as a walking aid for patients affected by cerebral palsy, for postoperative rehabilitation, polio, and other neurodevelopmental conditions. 139 Cervical cytology scraper, reusable Intended to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. It does not have any additional functional uses. 140 Cervical pillow Intended to provide support to people who have trouble keeping their spine straight and management of neck/cervical pain. 141 Cervical spine collar Intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). 142 Cervical traction head holder/head halter
Intended to be used with cervical traction kit to halt the head for physical support.
143 Cervical traction kit (with/without weights) Intended for traction of cervical region in conditions such as neck or back pain, post surgery rehabilitation, reducing neck pressure, etc. 144 Cervical traction spreader bar/ Spreader bar
Intended to serve as a component of a traction kit to relieve pressure by stretching the musculature and connective tissue components of the cervical spine.
145 Cervicothoracic spine orthosis Intended to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine. 146 Cervicothoracolumbosacral spine orthosis Intended to encompass the cervicothoracolumbosacral spine region of the neck and trunk. 147 Chair cushion, pediatric use A supportive seat shell intended for use with a disabled child to allow them to sit independently on a chair/swing/shopping trolley. 148 Chair, flotation therapy Intended to support a patient in a seated position and simulate floating using air-inflated cushions to aid in the prevention of pressure injuries as a result of reduced mobility and extended sitting postures. This is not intended for therapeutic purposes. 149 Chemotherapy spill clean-up kit, non-sterile Intended to safely clean and dispose of Chemotherapy drug spills. All components are supplied non-sterile. 150 Chest stand Intended to provide a stable and adjustable platform to position patients for accurate and high-quality chest/full body X-ray examinations.

151 Chest/Limb Restrainer Intended to be temporarily placed on or around chest or limbs of a patient’s body to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. 152 Chisel/osteotome blade handle A hand-held manual surgical device that is intended to function as a handle that mounts a compatible chisel/osteotome blade of these types which is locked into place. This is a reusable device.
153 Cholera bed Intended as a physical suppport for severely ill and weak patients including those suffering from cholera. 154 Cilia forceps A hand-held, manual, surgical instrument intended to facilitate the grasping and removal of the cilia (eyelashes). This is a reusable device intended to be sterilized prior to use. 155 Circumcision kit, reusable A collection of various non-sterile, non-powered, reusable instruments, dressings, etc. intended to perform a circumcision procedure. Typical components include circumcision clamp, scissors, and scalpel. This is a non-measuring, reusable device and does not contain pharmaceuticals. 156 Clamp for rubber dam A dental device intended to anchor a rubber dam down to the cervical region of an exposed tooth.
157 Clamp, reusable A handheld surgical instrument intended for clamping tissues or materials or bone other than in central circulatory/central nervous system. This is a reusable device intended for transient use. 158 Clavicle support/brace/belt Intended to support and limit the movement of clavicle bone in case of injury, fracture, post surgery, etc.
159 Cleaning solution for medical devices Intended to be used prior to disinfection for cleaning of medical devices such as dental suction units, etc. It is not a disinfectant for medical devices. 160 Closed-ended intestinal ostomy bag, multiple-piece A non-sterile plastic pouch intended to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy. 161 Cold compression therapy cervical spine collar/ Ice collar Intended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation, stiffness, whiplash).

162 Cold/cool therapy gel Intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling. 163 Collar and cuff arm sling Intended to immobilize forearm, elbow, humerus or shoulder injuries. 164 Colour discrimination non- prescription spectacles An ophthalmic device intended for use by people with color blindness to improve color discrimination and may also block UVA and UVB radiation from sunlight. 165 Colour discrimination tester Intended to test a person's ability to differentiate between colours. 166 Colour-discrimination eye chart Intended for testing colour vision. 167 Compression/pressure sock/stocking applicator Intended to assist in wearing/removing of medical compression stockings. 168 Compression/pressure tubular garment Intended to tightly fit over and apply compression/ pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema. 169 Conductive abrasive gel for skin preparation, non-sterile Non-sterile conductive gel intended to reduce the resistance (impedance) and defatting the skin in preparation for electrophysiological examinations: electroencephalography (EEG), long-term EEG monitoring, polysomnography (PSG), evoked potentials (EP), stress test ECG, ECG monitoring by Holter in clinics, hospitals, diagnostic centers. 170 Conductive electrode gel/paste (adhesive/non- adhesive), non-sterile A non-sterile gel intended to reduce resistance between skin and electrodes during examinations such as ECG, EEG, EMG, etc. 171 Congenital hip dislocation abduction splint Intended to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline). 172 Contact lens inserter/remover, non-sterile Intended to insert and remove contact lenses from the eye. It does not come in direct contact with the eyeball. This is a reusable device. 173 Controlled ankle motion (CAM) walker Intended for preventing/limiting foot/ankle movement in cases of serious sprain, surgery or removal of cast. 174 Corn/callus dressing, reusable The device is intended to offer symptomatic relief of physical foot disorders and similar conditions, by providing a mechanical barrier which relieves the effects of pressure and friction and or support.

175 Corn/callus dressing, single use A non-sterile adhesive dressing intended for protection and/or relief of corns or calluses (hardened areas of skin on the feet or toes).
176 Cotton and rubber elastic bandage It is an elasticated device intended to be worn on limbs for managements of sprains, strains and painful joints on intact skin. 177 Cotton crepe bandage It is intended to be worn on limbs for managements of sprains, strains and painful joints on intact skin. 178 Cottonoid pad, non-sterile A non-sterile absorbent device intended to absorb the saliva that is being secreted during dental procedures to maintain a dry field.
179 Cover for thermometer probe, non-sterile It is intended to act as a physical barrier between the patient and an in-the-ear thermometer to prevent cross-contamination between patients. 180 CPAP/BPAP chin strap, reusable A non-sterile device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during positive airway pressure (PAP) therapy to control mouth air leaks by gently holding the mouth closed. 181 CPAP/BPAP chin strap,single use A non-sterile, disposable device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during positive airway pressure (PAP) therapy to control mouth air leaks by gently holding the mouth closed. 182 CPAP/BPAP unit ambient air filter A non-sterile filter intended to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air; it is not intended to filter medical gases or microbes. 183 Cranial trephine, reusable A manual neurosurgical blade intended to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior, for various purposes such as catheter insertion, injection of dyes, etc. It is an exchangeable device that may be specifically attached to a manually-rotated handle only. This is a reusable device, intended for transient use. 184 Craniofacial rongeur, reusable for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery.

185 Crash cart/Emergency recovery trolley Intended for use in hospitals for transportation and dispensing of emergency medication/ equipment at the site of a medical/surgical emergency for life support protocols (equipment not included).
186 Crutches Intended to help transfer of load from the legs to the upper body of people who cannot use their legs to fully support the weight of their body due to temporary or permanent disabilities. 187 CT phantom, test object Intended to establish, validate, and provide for routine and periodic verification of patient imaging CT system performance consistent with internationally recognized standard. 188 Cystoscopic rongeur, reusable A rigid, hand-held manual instrument intended to be used with a compatible rigid cystoscope for the removal of hard/tough tissue (e.g., calculi) from the urinary tract during a cystoscopic procedure. It is introduced into the body through an artificial orifice or the working channel of the endoscope. This is a reusable device. 189 Cytotoxic waste receptacle Intended to safely deposit, collect and store cytotoxic materials (e.g., chemotherapy/ antineoplastic drugs). 190 Dappen dish, reusable A non-sterile, reusable vessel intended to contain and mix dental materials chairside prior to application to the patient during dental procedures. 191 Dappen dish, single-use A non-sterile, disposable vessel intended to contain and mix dental materials chairside prior to application to the patient during dental procedures. 192 Denis Brown splint Intended to immobilize the foot, particularly on young children with tibial torsion (excessive rotation of the lower leg) or club foot. 193 Dental abrasive disk guard A dental device intended to be fitted around an abrasive disk when rotating at high-speed to protect tissues not intended to come in contact with the abrasive disk. 194 Dental abrasive disk, reusable A non-sterile dental lab instrument intended for use in contouring, finishing, and polishing dental restorations. Not intended for direct patient contact. 195 Dental abrasive disk, single- use A non-sterile dental lab instrument intended for use in contouring, finishing, and polishing dental restorations. Not intended for direct patient contact.

196 Dental abrasive strip, reusable It is intended to be used for cleanup, polish or finish dental crowns and bridges after cementation of crowns, veneers, bridges, inlays or onlays. Not intended for direct contact with tooth. 197 Dental abrasive strip, single- use It is intended to be used for cleanup, polish or finish dental crowns and bridges after cementation of crowns, veneers, bridges, inlays or onlays. Not intended for direct contact with tooth. 198 Dental amalgam mixer This is a dental benchtop device intended to mix by vibration/shaking, encapsulated materials to be used for dental restorative procedures in the mouth.
199 Dental articulation liquid A range of pressure indicating material intended to locate areas of denture or removable dental device discomfort in the patients mouth for seating crowns, bridges, full dentures, immediate dentures and partial dentures. 200 Dental articulation paper Intended for marking areas of contact between opposite teeth, restorations or appliances. 201 Dental articulation paper forceps A hand-held manual dental instrument intended for grasping and holding articulation paper during its application to a patient's oral cavity. This is a reusable device. 202 Dental automated x-ray film processor A mains electricity (AC-powered) automated dental x-ray film processor intended for the rapid processing of dental x-ray films.
203 Dental camera cover, non- sterile A non-sterile device intended to provide an infection-control protective barrier for dental
intra-oral camera. 204 Dental cheek retractor, home-use This is a hands-free, self-retaining frame that is intended for home use by a patient to retract the lips/cheeks to facilitate viewing of the teeth. 205 Dental cheek retractor, professional A non-sterile, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It may also be designed to displace the tongue. It is not intended to connect to an active device. 206 Dental cotton roll, non-sterile It is intended as an absorbent, hard-packed cylinder (a roll) that is used as a saliva absorber from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. Not intended for long-term use.

207 Dental cuspidor This is a vessel, e.g. a round bow, into which the patient may expectorate during and after dental procedures.
208 Dental dressing forceps, reusable A hand-held manual dental instrument intended for grasping and holding a dental dressing during its application to a patient's oral cavity. This is a reusable device. 209 Dental elevator, sinus lift, reusable A hand-held, manual, dental surgical instrument intended to lift and displace sinus mucosa (Schneiderian membrane) from the maxillary sinus floor to allow for insertion of a bone graft during sinus lift surgery. This is a reusable device intended for transient use. 210 Dental elevator, tooth/root, reusable A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. This is a reusable device intended for transient use. 211 Dental examination kit, reusable A collection of non-sterile dental instruments (forceps, mirror, probe, spatula, excavator) intended to be used to perform general dental examination. It is not intended for surgical procedures. Kit does not contain any dental implants, medicines/substances or fill materials. This device is reusable intended to be sterilized prior to use. 212 Dental excavator, reusable A manual, non-sterile surgical instrument intended for cutting, cleaning and shaping a carious cavity before filling it. This is a reusable device. 213 Dental float/rasp, manual (for veterinary use) Intended for periodic grinding of teeth of animals with continuously growing teeth, such as cattle and horses, in order to aid in proper chewing and prevent injury to cheeks and oral cavity.
214 Dental floss It is a tape/thread-like device intended for removing plaque, tartar, etc. from between the teeth and aid in prevention of dental caries. 215 Dental handpiece cover, non-sterile A non-sterile device intended to cover and protect a dental handpiece during dental procedures and prevent cross-infection between patients. 216 Dental implant abutment analog, laboratory A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.

217 Dental implant abutment impression cap A device intended to be placed intraorally on the abutment head of a dental implant during dental impression procedures, to facilitate the removal of the impression material after setting and to ensure the position of the implant in order to transfer it to a working model for the dental technician.
218 Dental implant abutment trial A copy of a dental implant abutment intended to be used intraorally during dental implant restorative procedures to reproduce the characteristics of an abutment (e.g., angle, diameter, transmucosal or cementable area height) to facilitate selection of an appropriate final prosthetic abutment. This is not a dental implant. This is a reusable device. 219 Dental implant extractor, reusable This is a manually-operated, dental device that is intended to be used to retrieve a dental implanted device, typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. 220 Dental implant/prosthesis handling forceps, reusable This is a hand-held manual dental instrument intended for grasping and holding a dental devices(e.g., crown, bridge, screw) during its application to a patient's oral cavity. This is a reusable device. 221 Dental impression adhesive
A liquid material specifically intended to give adhesion of an impression material to the impression tray. 222 Dental impression material intended to be used in dentistry to reproduce the structure of a patient's teeth, gums or other oral tissues. 223 Dental impression material kit, reusable A collection of non-sterile devices intended to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s). 224 Dental impression material kit, single-use A collection of non-sterile devices intended to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s).
225 Dental impression material mixer An electric device intended to mix impression materials immediately before use at the chair side. 226 Dental impression material syringe A non-sterile, hand-held manual dental instrument intended to be used to inject impression material into an impression tray. This

227 Dental impression spacer A device intended to be temporarily applied to the surface of edentulous ridges and dental structures before the preliminary application of impression material. This is a non-sterile, single- use device. 228 Dental impression tray material A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. 229 Dental impression tray, reusable It is intended to hold impression material, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression.
230 Dental irrigation/aspiration syringe, reusable A hand-held manual dental device (a plunger- type syringe) intended to inject and/or aspirate a volume of solution into the working area in the oral cavity. This is a reusable device. 231 Dental laboratory bur, reusable A rotary cutting device intended to fit into a dental laboratory handpiece that provides the rotation for dental laboratory use only to cut hard structures (e.g., metals, plastics, porcelains), during the fabrication of dental restorations. This is not intended for in-patient use. 232 Dental laboratory curing light An electrically-powered device intended to be used in the dental laboratory for curing polymer- based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. It is not a measuring device. 233 Dental material application tool, reusable Intended to be used in dentistry for the application of a dental material (e.g., composite resin, etchants, etc.) to a dental prosthesis or to a patient’s tooth/teeth or elsewhere in the oral cavity. 234 Dental material heater Intended to heat regular (paste) and flowable composite material, including bulk fill composites, compules, porcelain veneers and onlays. 235 Dental material mixing nozzle, non-sterile A device intended for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material (not included) which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. 236 Dental material mixing surface, reusable Intended to be used as a surface to mix dental materials.

237 Dental material mixing surface, single-use Intended to be used as a surface to knead or mix dental material (impression material, cement, etc). 238 Dental matrix band, reusable A dental instrument intended to contour a dental restorative material to match dentition within the oral cavity. This is not a dental implant.
239 Dental matrix band, single- use, non-sterile A dental instrument intended to contour a dental restorative material to match dentition within the oral cavity. This is a non-sterile, single-use device. This is not a dental implant. 240 Dental matrix wedge Intended for use as a wedge between teeth to create space when applying restorative materials. 241 Dental precision attachment fitting/adjustment tool, reusable This is a hand held, manual dental laboratory instrument that is intended to be used in a dental laboratory or dental surgery during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. This is a reusable device. 242 Dental prosthesis/implant abutment screw analog, reusable/ Guide pin, reusable A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. It is not a dental implant. 243 Dental resin applicator Intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. 244 Dental rongeur, reusable A hand-held, manual instrument intended to be used in dental surgery to remove hard or tough body tissues such as cartilage or bone, by applying a biting/cutting action. This is a reusable device intended for transient use. 245 Dental rubber dam clamp forceps, reusable A hand-held dental instrument intended for the insertion and removal of rubber dam clamps.
246 Dental rubber dam, non- sterile A non-sterile dental device intended to be placed over the teeth during dental procedures for uses such as 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection.

247 Dental soft-tissue coring punch, reusable A manual dental instrument intended to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. This is a reusable device. 248 Dental spatula A hand-held, manual device intended for kneading or mixing dental material (impression material, cement, etc). This may be reusable or single-use. 249 Dental suction protective mouthpiece A prefabricated device intended to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue. 250 Dental suction system fluid- separation unit A separator used in the oral cavity for the separation of fluids (saliva, blood) from gases to avoid liquids from entering the suction pump (i.e., dry suction). Suction pump is not included. 251 Dental surgical microscope This is a dental device that is intended to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures in the mouth. 252 Dental surgical probe, reusable A hand-held manual dental surgical instrument intended to be used to explore and/or perform therapeutic procedures during various types of dental surgical intervention. This is a non- measuring, reusable device. 253 Dental torque wrench adaptor It is intended to enable connection of the main body of the wrench to a specific endpiece(s). It is intended for transient use. 254 Dental wedge (for veterinary use) Intended for use during dental examination/treatment to retract soft tissues from teeth, isolate a teeth for treatment/examination purposes, etc.. This is a reusable device. 255 Dental X-ray beam aligner Intended to assist the dental radiographer to align the positioning indicator device relative to the tooth and receptor. 256 Dental X-ray film holder It is used to hold the dental X-ray films and position it to the right angle inside the mouth to aim taking an accurate X-ray. 257 Dental/oral lavage unit (water flosser) Intended to inject a stream of water on teeth to remove dental plaque in between teeth and improve gum health. It is intended as an OTC (home use) device.

258 Dental-professional prophylaxis brush/Dental polishing brush A rotary dental instrument intended to be used by a dental hygienist and/or dentist to clean and polish teeth. 259 Dentifrice/ Dental polishing paste Prophylaxis pastes without fluoride intended to be used by professionals for tooth cleaning and polishing procedure by abrasion/mechanical cleaning only.
260 Dentures cup This cup is intended to hold patient dentures when they are not in the mouth. 261 Dermatome skin approximation tape Intended for attachment onto a skin graft knife to collect a skin graft tissue. 262 Dermatome, manual, reusable A hand-held, manual surgical instrument used for cutting thin donor slices of skin for skin grafting or for excising small skin lesions. This is a reusable device. 263 Dermatoscope, digital Intended for non-invasive, visual inspection of intact skin by a healthcare professional. It does not have measuring function. 264 Derotation bar with Traction Intended for lower limb traction and aid in early healing, correction of drop foot. 265 Diagnostic condensing lens A non-sterile ophthalmic lens intended for use in binocular indirect ophthalmoscopy to focus reflected light from the fundus of the eye.
266 Diagnostic X-ray system positioning frame Intended to be placed on the floor to position and support a patient, an x-ray tube assembly (not included), and an image receptor assembly (bucky) (not included) during a diagnostic x-ray procedure. 267 Diagnostic x-ray tube mount Intended to support and to position the diagnostic x-ray tube housing assembly (not included) for a medical radiographic procedure. 268 Dialysis bag clamp/clip Intended to be used for opening or closing the dialysis tube. 269 Dialysis set holder Intended to hold and secure in position a dedicated set being used during a dialysis procedure. 270 Diaphragm wearable urinal A non-sterile urine drainage device intended to be used by men with incontinence for urine collection. This is not a catheter. This is a reusable device. 271 Digital examination camera
Digital camera for close-up skin inspections or general examinations. 272 Direct ophthalmoscope eye cup The device is intended to be attached to the distal (patient-contact) end of a direct ophthalmoscope head to facilitate appropriate positioning around the patient’s eye socket during an examination. 273 Disposable Kelly pad Intended to funnel blood to a collection device in order to help detect postpartum hemorrhage. It does not have measuring function.

274 Dissection board A reusable device on which an object is placed for support during dissection procedures. 275 Douche kit A packaged collection of non-sterile items (douche solution prefilled in a douche unit) intended to provide cleansing of the vaginal area. 276 Drape adhesive Intended to be placed on the skin to attach a surgical drape. 277 Draping incontinence liner A non-sterile padded sheet intended to cover a device/piece of furniture (e.g., wheelchair, bed, sofa) occupied by an incontinent person to catch and retain urine. 278 Dressing retention garments Intended for use in wet and/or dry wrapping and dressing retention in the treatment of atopic eczema. This does not incorporate anti-microbial agents. 279 Dressing trolley Intended to store and transport medical dressings within a hospital/health care facility. This does not include dressings. 280 Dressing/utility forceps, reusable A hand-held manual instrument intended primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. This is a reusable device intended to be sterilized prior to use. 281 Drip wearable urinal A non-sterile urine drainage device intended for men to contain a moderate leakage and urine collection. 282 Driver/extractor, reusable A hand-held, manually-operated, combination surgical instrument intended to be used in the insertion and/or removal of, e.g; a pin, screw or appliance during surgical procedures. This is a reusable, non-measuring device intended for transient use. 283 Dry powder inhaler Intended to administer powdered medicine through the mouth and into the bronchial airways. 284 Dry salt therapy device Intended to provide an inhalation of prefilled salt particles through the mouth and into the bronchial airways to induce natural self-cleansing mechanisms that flush away the impurities from the surface of cells and mechanically clean the airways. 285 Ear bowl Intended to fit the curvature of the head and sit closely under the ear lobe to enable ear treatments.

286 Ear canal impression tray Intended to hold and confine the impression material in opposition to the surfaces to be recorded, and to control the impression material while it sets to form the impression of the ear canal. 287 Ear canal light Intended to illuminate the ear canal. 288 Ear hook, reusable A hand-held, manual surgical instrument intended to be used in surgery of the middle ear. This is a reusable device intended for transient use. 289 Ear Irrigation kit A collection of non-sterile items intended to irrigate the ear canal with solution to clear wax and debris. It may consist of curette, forceps, a manually-operated flushing device (e.g., spray bottle, syringe, etc.) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device. 290 Ear speculum, reusable / Ear cannula, reusable A device that is hand-held and manually inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It might also be referred to as an ear probe. This is not intended for long-term use and cannot connect to high-risk active devices. This is a reusable device. 291 Earmould impression kit A collection of non-sterile, non-active supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs.
292 Earmould impression material A silicone impression moulding material intended to take an impression to manufacture a shell or ear mould to the correct size to fit an individual's ear. 293 Elastic adhesive Bandage It is intended to secure dressings and for strapping on intact skin. 294 Elasticated cohesive Bandage It is intended to secure dressings and for strapping on intact skin. 295 Elbow immobilizer A non-rigid external device intended to temporarily render the elbow immovable to support healing of an injury or a surgical wound. 296 Elbow orthosis A wearable orthopaedic appliance intended to externally encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow.

297 Electric dental chair without operative unit A mains electricity (AC-powered) device intended to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It does not include operative unit. 298 Electric linear actuator with/without control box A device in its finished form, specifically designed and intended to control the movement of electric medical beds, operation tables, etc.
299 Electric stander Intended to be used as standing frames for those with standing difficulties. 300 Electric toothbrush Intended to remove plaque, tartar, etc. from teeth and gums and aid in prevention of dental caries, etc. 301 Electrical-only medical device connection adaptor This device connects incompatible plugs/sockets on related medical devices (e.g., video control centers, peripheral devices and controller) and/or cables and relates the control signals. 302 Electrical-only medical device connection cable, reusable A non-patient-contact, electrical cord with a connector (plug) at both ends intended to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. 303 Electrode/transducer strap, reusable A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface. This is a reusable device. 304 Electronic occlusion spectacles Intended to test and train vision for conditions where decreased visual acuity may be due to unequal vision in the eyes. 305 Electrosurgical electrode holder
A device intended to be used to house active hand-controlled electrosurgical electrodes (pencil electrodes) when not in use during the surgical procedure. The electrosurgery electrodes are not included. 306 Elevator, ear/nose/throat A hand-held, manually-operated, surgical instrument intended to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It does not have any additional intended uses. This is a reusable device.

307 Elevator, orthopaedic, periosteal/ Periosteal elevator, reusable
to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. This is a reusable device intended for transient use. 308 Elevator, orthopaedic/ Bone lever/elevator, reusable A manual surgical instrument intended to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. This is a reusable device intended for transient use. 309 Elevator, uterine A hand held surgical instrument that is intended to be inserted into the uterus to manually lift and manipulate this structure during gynecological surgery. This is a reusable device.
310 Emesis bag A disposable device intended to collect and contain a patient's vomit and eliminate exposure to vomit until it is convenient to dispose of the bag and its contents. Intended for hospital use. 311 Endaural wax extraction curette A hand-held, manual, non-surgical device intended to scrape within the ear canal primarily for the extraction of ear wax during an ear/nose/throat (ENT) procedure; it is not intended for surgical scraping or manipulation of tissues.
312 Endodontic plugger, reusable A hand-held, manually-operated, dental instrument specifically intended to compress filling materials in a root canal, mainly in an axial direction. This is a reusable device. 313 Endoscope calibration cover, reusable A plastic cap/cover intended to be placed onto the distal end of an endoscope (not included) to allow white balance and/or 3-D adjustment to be calibrated in the electronic control unit of the endoscope. This is a reusable device. 314 Endoscope camera adaptor/coupler, reusable An optical device intended to connect/couple a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers.This is a reusable device.

315 Endoscope camera, noninvasive A non-invasive device intended to provide illumination, visualization and capture of still and motion pictures of surgical sites during diagnostic and operative arthroscopic and endoscopic procedures, without having a measuring function.This may include accessories such as camera holder, cable, charger, batteries. This does not include endoscope. 316 Endoscope channel cleaning valve An adapter or valve to be fitted to an endoscope for cleaning purposes. 317 Endoscope cleaning brush A device intended to remove dirt or debris from the working channel (s) and irregular surface of the endoscope prior to disinfection and sterilization.
318 Endoscope collector A device intended to collect the excreted endoscopic video capsule camera. 319 Endoscope flushing adaptor An adapter intended to be fitted to an endoscope air/water channel for flushing of the endoscope during post-procedural ‘precleaning’ step of endoscope reprocessing after endoscopic procedure. 320 Endoscope leak tester tubing Intended to deliver air or any other medium from a leak tester to the interior of an endoscope during a leak test. 321 Endoscope Storage Cabinet Intended for storing (and drying) endoscopes after their disinfection and maintaning a microbe- free environment. This is not intended for disinfection or sterilization. This may be an accessory of a disinfector.
322 Endoscope/instrument holder, noninvasive, manually-adjusted A noninvasive, manually adjusted device intended to be used to hold, maintain in a desired position, and enable positional adjustment of an endoscope (e.g., laparoscope) and/or associated instruments/devices during an endoscopic examination/surgical procedure.
323 Endoscopic biopsy valve, reusable A non-sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. 324 Endoscopic irrigation/aspiration foot- pedal A manual, foot-operated device intended to be used in conjunction with an irrigation tubing set (not included) to facilitate delivery of sterile irrigation fluid by displacing a syringe plunger (not included).

325 Endoscopic video image processor A unit intended to receive receive and process electronic video image signals sent from the endoscope (not included). It is not intended to control the endoscope. This is not an image analysis tool. 326 Endotracheal tube holder A non-sterile device intended to provide a reliable stabilization of endotracheal tube (not included) after intubation. 327 Endotracheal tube introducer, reusable Intended to help with the insertion of an endotracheal (ET) tube (not included) into the airways of a patient during intubation. This is a reusable device. 328 Enema bag
Intended to be used to hold an enema solution for administration into the rectum. 329 Enema tip, reusable A non-sterile device intended to be connected to an enema tube to facilitate delivery of an enema solution into the rectum. This is a reusable device. 330 Enema tube, non-sterile A non-sterile length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum. 331 ENT chair, electric without operative unit Intended to support a patient in a seated position, electrically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. This does not include any diagnostic or surgical instruments. 332 ENT chair, mechanical without operative unit Intended to support a patient in a seated position, mechanically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery. This does not include any diagnostic or surgical instruments. 333 ENT foreign body extraction forceps, reusable A hand-held, manual, non-surgical device intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. This is a reusable device. 334 ENT illuminating foreign body extraction set A collection of devices which includes a foreign body extraction instrument (typically a curette or forceps), and an electrically-powered light source, and a magnifying lens intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. It is supplied non-sterile and is non- measuring.

335 ENT illuminator Intended to assist with examinations by illuminating regions of the eye mount or ear. It does not have a measuring function. 336 ENT Nasal snare, reusable to be inserted into the naris for the removal of tissue, typically polyps, tumours, and other abnormal tissue from the nasal cavity during ear/nose/throat (ENT) surgery. This is a reusable device. This is not an active device. 337 ENT speculum holder A device intended to be used to secure an ear/nose/throat (ENT) speculum in a fixed position to enable a surgeon to remain hands- free during a surgical intervention. This is a reusable device. 338 ENT surgical excavator, reusable An ear, nose, and throat reusable manual surgical instrument intended for use or to assist in use in surgical procedures to examine the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This is a reusable device intended to be sterilized prior to use. 339 ENT surgical microscope Intended to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing. 340 ENT transilluminator Intended to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination. 341 Enteral feeding/decompression tube clearing stem A non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency. 342 Enteric stomal shield A non-sterile cap intended to be placed over an enteric stoma to protect it from harmful external influences (e.g., knocks, friction). 343 Enuresis alarm/ Incontinence sensor It is intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It does not have a measuring function. 344 Epileptic seizure alarm Intended to alert or notify healthcare professional or next of kin when an epileptic patient (often pediatric) gets a seizure attack.

345 Euthyscope A hand-held device intended to project a bright light encompassing an arc of approximately 30 degrees on the fundus of the eye for the treatment of amblyopia. This is a non-measuring, reusable device. 346 Extension Plaster –width wise stretchable A non-sterile device intended to secure dressings and for strapping on intact skin. 347 External arm prosthesis socket A device intended to fit over the terminal end of a residual upper limb and serves as an interface between the limb and an artificial replacement arm segment (external prosthesis). 348 External arm prosthesis, pediatric, non-powered External non-powered artificial hand or arm prosthesis for physically disabled pediatric patients.
349 External asembled lower limb prosthesis Intended for use as an preassembled external artificial limb for the lower extremity.
350 External limb orthotic component A device intended for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs, e.g., stirrups, etc.
351 External limb prosthesis socket liner Intended for use as an interface that goes between a person's skin and his or her external prosthetic to protect the wearer's skin while enhancing comfort and maintaining a more consistent fit. 352 External limb prosthetic component A non-measuring, non-active device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis (non-active), e.g., socket components, suction valves, etc. 353 External lower-limb prosthesis socket A component of an external lower limb prosthesis intended to fit over a residual limb after amputation at any hip, knee, or ankle-foot level, and intended to function as the limb-prosthesis interface and to provide support, stabilization and suspension.
354 External nasal splint Intended for external use for immobilization of parts of the nose (nasal bone/cartilage) typically after a fracture or surgery. 355 External silicone breast prosthesis Intended to restore normal contour and improve function for patients who have experienced partial or total loss of their breast to traumatic injury, disease or due to surgical removal of the nose (rhinectomy). 356 Extractor, reusable It is a hand-held instrument intended to aid in the removal of foreign objects from superficial skin tissue. This is a reusable device.

357 Eye cup A cup-shaped device, supplied non-sterile, intended to fit around the eye socket and placed over the eye to allow washing of the affected eye. 358 Eye heat therapy mask, self- heating, single-use A non-sterile, self-heating device intended for delivering moist heat to the eyes for relief in dry eyes syndrome, fatigue, soreness, meibomian gland function, etc. 359 Eye irrigation shield Intended for use with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye. 360 Eye pad, non sterile Intended for use as a bandage over the eye for protection or absorption of secretions. 361 Eye patch, non-sterile A device with a synthetic origin used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention or as a occluder for vision or field testing. 362 Eyelid clamp, reusable to atraumatically grasp and hold the eyelid during an ophthalmic surgical intervention. This is a reusable device. 363 Eyelid speculum, reusable A self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. This 364 Eyelid weight, external Intended to be applied to the outside of the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle function. This device can be used for: 1) the treatment of temporary facial paralysis caused by Bell's palsy, trauma, or a stroke; or 2) to determine the appropriate size of implantable eyelid weights prior to surgery.
365 Face shield Intended to protect a health care professional's entire face (or part of it) from chemical splashes, particulates, potentially infectious materials, etc. (in medical and laboratory environments). 366 Feeding nipple Intended for use as a feeding nipple for infants with oral or facial abnormalities. 367 Felt tangent screen Intended for assessing the extent of the patient's peripheral visual field by mapping the visual response to a test object moved from the periphery towards the centre of the screen.

368 Female wearable urinal, reusable A non-sterile, external urine drainage device intended for women specially formed to securely fit around the female genitals for urinary incontinence management by providing a route to channel urine, via a tube, into a collection bag. 369 Fiber cast bandage Intended to be used as a medical dressing to support and protect bones that have been broken or joints that need stabilization.
370 Fibreoptic general-purpose ophthalmic hook, reusable A hand-held, manual surgical instrument inserted into the eye during surgical intervention to manipulate anatomical structures or foreign bodies within the eye and simultaneously conduct a field of cold light to illuminate the surgical site. This is a reusable device intended for transient use. 371 Fibreoptic vaginal speculum A hand-held manual instrument intended to dilate and illuminate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It does not have any additional features/intended purposes and cannot connect to high-risk active devices. This is a reusable device. 372 Filter adapter (Spirometry accessory) Intended to connect a filter with different spirometers. 373 Filter for dental suction equipment Intended to be fitted in the suction line of a dental suction system (e.g., in the saliva ejector valve) to trap debris [e.g., amalgam, bone particles, dentin/enamel particles] and stop them from entering the mains drainage system during a dental procedure. This is not an autologous bone collector. This is a reusable device 374 Filter for gas central supply system Intended to remove particulates and volatile organic compounds (VOCs) from the gas flowing into incubators used in IVF procedures.
375 Finger and toe bandage Intended to be worn over/around the limb (arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury. 376 Finger Cot/brace Intended to support, align, prevent or correct deformities/injuries or to improve function of finger.

377 Finger protector, non-sterile A glove-like device intended to be worn on the finger(s) to protect fingers during insertion of devices such as suppositories (not included) through the body orifice(s). This is not intended for surgical purposes. 378 Finger/hand exerciser Intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity or density (post fracture/stress/weak forearm and grip strength). 379 Finger/thumb prosthesis Intended as an artificial substitute for a missing finger or thumb. 380 Fistula hook, reusable A hand held, manual surgical instrument intended for hooking into or around a fistula during a surgical intervention. It is a reusable device intended for transient use. 381 Fistula probe, reusable for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an external cavity or to the surface of the body. It is mostly used to explore and/or dilate strictures inside a fistula and not intended for probing heart valves. This is a reusable device. 382 Flatus tube, reusable A tube intended to be inserted through the anus to remove flatus and relieve distension in the rectum. This is a reusable device. 383 Flex bar Intended to increase tendon strength and reduce elbow pain for those who suffer from tennis and golfer's elbow.
384 Flieringa ophthalmic ring A circular band, sutured to the sclera to prevent collapse of the globe during difficult intraocular operations. This is a reusable device intended for transient use. 385 Flotation therapy bed, neonatal A non-powered, fixed (non-adjustable) device intended to be used for the continuous care of newborns, and sick and/or premature babies.
386 Fluid delivery mount, general-purpose The device is intended to hold the fluid bags when gravity irrigation is needed for scope surgery.
387 Fluted surgical drill bit, reusable A shaft of metal intended to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This is a reusable, non-measuring device intended for transient use.

388 Foot traction kit It is used in relieving pain due to muscle spasm, maintaining the limb in a position of comfort and to restore and maintain the alignment of bone due to fracture or dislocation. 389 Footstool, conductive A conductive low stool for standing on to compensate for height differences. It is intended to be used in health care settings, e.g. examination rooms or operating theatres, etc.. 390 Forceps jar A cylindrical vessel intended for holding various types of forceps prior to and during a surgical intervention or an examination in an operating room (OR) or examination room. This is a reusable device. 391 Forceps, biopsy/Open- surgery biopsy forceps, reusable to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. 392 Forceps, bone, reusable to grasp, manipulate, cut or crush bone. This is a transient use, reusable device intended to be sterilized prior to use. 393 Forceps, dental, reusable A reusable hand-held dental instrument used in the mouth for gripping applications. 394 Forceps, dissecting, tweezers/scissors-like, reusable intended to facilitate grasping, manipulation, compression or joining of tissue during dissection and/or autopsy. This is a transient-use, reusable device intended to be sterilized prior to use. 395 Forceps, dressing A hand-held manual instrument intended primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. This is a reusable device intended to be sterilized prior to use. 396 Forceps, ear/nose/throat/ENT forceps, reusable A general-purpose ear/nose/throat (ENT) manual surgical instrument intended to facilitate the grasping, holding, or manipulation of anatomical structures (e.g., trachea, ear) or devices (e.g., cochlear implant electrode array) during ENT procedures. This is a transient-use, reusable device intended to be sterilized prior to use.

397 Forceps, gallbladder, reusable intended to atraumatically grasp or manipulate the gallbladder. This is a reusable device intended for transient use. 398 Forceps, general-purpose for general-purpose grasping/picking up of other devices/objects typically with the intention of maintaining a sterile condition or avoiding direct hand contact because of unhygienic/unfavourable conditions. This is a reusable device. 399 Forceps, gynaecological/Gynaecologic al grasping forceps, reusable to be used for the general grasping, pulling, or compression of internal structures during a gynaecological surgical intervention; they are not intended for laparoscopic use. This is a transient- use, reusable device intended to be sterilized prior to use. 400 Forceps, haemostatic, reusable to constrict blood vessels during surgery to prevent bleeding for transient period of time. This is a transient-use, reusable device. 401 Forceps, intestinal, reusable for the atraumatic holding/grasping and/or compression of intestinal structures, tissues, and some organs during a surgical procedure. This is a reusable device intended for transient use. 402 Forceps, kidney, reusable A manual, scissors-like surgical instrument intended to grasp, manipulate or support the kidney. This is a reusable device intended for sterilization prior to use. 403 Forceps, obstetric, general- purpose, reusable A scissors-like obstetrical instrument intended specifically to assist the birth of the foetus during difficult vaginal births. This is a reusable device. 404 Forceps, sterilizer transfer A hand-held, scissors-like, manual surgical instrument intended to grasp and handle sterile instruments, packages, or implants, especially directly from a sterilizer. This is a reusable device. 405 Forceps, stone removal/Open-surgery stone-retrieval forceps, reusable to grasp and/or manipulate a calculus (i.e., a kidney or gallbladder stone) during an open surgical procedure; additional intended uses may include soft-tissue manipulation (e.g., polyp removal). This is a transient-use, reusable device intended to be sterilized prior to use. it is not intended for laparoscopic/endoscopic use.

406 Forceps, Tooth extraction, reusable A hand-held manual dental surgical instrument intended for the extraction of teeth. This is a reusable device. 407 Forceps, wire/Wire holding/twisting forceps, reusable A manual surgical instrument intended to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. This 408 Fornixscope A manually-operated ophthalmic device intended to provide indirect access and viewing of the upper conjunctival fornix and inner surface of the eyelid as an alternative to eyelid eversion. 409 Freestanding patient lifting system, electric A non-powered, non-mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Repositioning of the assembly may be achieved by lifting it to a new position/location. 410 Freestanding patient lifting system, manual A non-powered, stationary assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Repositioning of the assembly may be achieved by lifting it to a new position/location. 411 Fresnel lens Intended to be applied to the back of spectacle lenses to focus light to a focal point to help manage various vision conditions. 412 Fresnel prism Intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction. 413 Fundus camera It is intended to capture and document digital images of the posterior and anterior segments of the human eye. 414 Fundus camera, pediatric Intended to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while their eyes are dilated using mydriatic drops under clinical control.

415 Gait rehabilitation electronic walker It is intended to assist a patient with a walking disability (neurogenic, muscular, or orthopaedic in origin) to regain lost motor function, which may include rising from sitting to standing and/or ambulation over ground (not on a treadmill). It is intended to be used in a clinical setting under healthcare professional supervision. This does not have a measuring function (e.g., vital monitoring, distance measurement, etc.). 416 Gait Trainer, non-powered A non-powered device intended to assist and train a person with physical disabilities to relearn/improve walking.
417 Gas cylinder trolley A dedicated cart designed to hold and secure one or more medical gas cylinders of compressed gas (not included); but may be used for other types of gases, both during transport and static placement. Intended for hospital use. 418 Gas sampling line filter, reusable A screening device intended to be installed in a reusable gas sampling line or gas measuring instrument (not included) to remove moisture, from the gas, to help minimize damage to the measuring instrument from gas condensation. It does not have a measuring function. 419 Gastric pH strip Intended to be used to indicate the pH level of human gastric aspirate. 420 Gastrointestinal ostomy tube pocket A non-sterile, noninvasive pouch intended to be wrapped around the protruding end of a gastrointestinal ostomy tube (e.g., gastrostomy or jejunostomy tube) to hold and support it in order to ensure its stabilization on the patient. 421 Gel base for metallic neuro head frame
It is used for providing support patient's head in a suitable and stable position (e.g., supine, lateral, or prone) during intracranial and spinal surgeries. 422 Gel knee ring
Intended to be worn around the knee for pain relief and immobilization. 423 Gel-filled bed mattress Intended to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. This is a non-active device.

424 Gel-filled bed mattress overlay Intended to be placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores.
425 Gel-filled chair cushion A gel-filled pad intended to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. 426 General external orthopaedic fixation kit, reusable A collection of non-sterile, non-measuring, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes include instruments, such as retractors, rods, clamps, drills, saws, screwdrivers, guides, impactors, intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. The surgically invasive components of this kit are intended for transient use only. 427 General internal orthopaedic fixation system implantation kit, reusable, non-measuring A non-dedicated collection of hand-held, manual, non-measuring instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial).It includes reusable devices for transient use [retractors, rods, clamps, drills, guides, saws, screwdrivers, impactors, etc.]; the implant(s) is not included. This is a reusable device. 428 General-gas low pressure tubing, reusable Intended to deliver nitrogen or instrument air to the console from the wall in the hospital. This does not include measuring devices. 429 General-purpose curette, reusable for scraping and/or excising tissue from a wide variety of anatomical sites, and may include non- dermal application (i.e., non-dedicated). Not intended for direct contact with the central circulatory or the central nervous system. This is a reusable device intended to be sterilized prior to use. 430 General-purpose diagnostic x-ray phantom, anthropomorphic A device intended to be used as a tissue- equivalnent model and mimic the functional, physical, or a combination of these characteristics of a normal or diseased human organ or organ systems.

431 General-purpose diagnostic X-ray phantom, test object Intended to provide for routine and periodic verification of the energy, hardness and intensity of an X-ray beam. 432 General-purpose manually- operated operation table A mobile, manually-operated hydraulic table intended to be adjusted to support a patient during many types of surgical interventions. 433 General-purpose patient lifting system sling/harness A general-purpose lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. This is a reusable device. 434 General-purpose surgical spatula, reusable to manipulate tissue during various types of surgical interventions. This is a reusable device intended for transient use. 435 General-purpose diagnosis/treatment table Intended for use in general diagnosis and procedures in examination room to aid patient examination. 436 Gingival barrier (non- medicated) Intended for protection of gingival area during tooth bleaching process. 437 Gonadal radiation protector Intended to attenuate unnecessary radiation exposure in diagnostic, medical or dental procedures, and shield the gonad of the patient and the operator. 438 Gonio lens/ Gonioscope A hand-held device intended for viewing the anterior chamber angle and retina. 439 Gravity enema set, non- sterile A set of non-sterile device intended to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. 440 Grip-enhancing exoskeleton Intended to improve grip strength and hand function for people (from children to elderly people) with impaired hand function. The condition may be (but is not limited to) due to orthopaedic or neurological problems, from birth or acquired. This does not have a measuring function. 441 Gynaecological bib Intended to be worn by the patient during gynecological examinations and procedures. 442 Gynaecological biopsy forceps, reusable to obtain biopsy specimens from gynaecological tumours or other gynaecological tissues for histopathological examination. This is a reusable device. It is not intended to be connected to an active device. 443 Gynaecological operating table top Intended to support a patient during gynaecological surgical procedures.

444 Gynaecological operating table, electrohydraulic or electromechanical or hydraulic Intended to support a patient during gynaecological surgical procedures. 445 Gynaecological polypectomy forceps for the transvaginal removal of polyps from the vagina and uterus. This is a reusable device. This is not intended to be connected to an active device and intended for transient use. 446 Gynaecological surgical microscope Intended to improve visualization of anatomical structures via transmitted light during
gynaecological surgery (e.g., on the fallopian tubes). 447 Gynaecological examination/treatment table Intended to support a woman's body in the appropriate positions during gynaecological examinations. 448 Gynecological couch (examination table) To support a woman's body in the appropriate positions during gynaecological examinations. 449 Haemodialysis chair, electrically powered/Manual Intended to support the patient in a seated or reclined posture during haemodialysis procedures. 450 Haidinger brush imager Intended to produce an image which facilitates visual function evaluation, particularly the macular integrity. 451 Hallux valgus metatarsophalangeal orthosis A prefabricated (non-customized) non-rigid, home-use device intended to be worn on the foot to help prevent and/or reduce hallux valgus deformity, thereby reducing walking pain and bunion formation. 452 Hand exerciser table This modality exerciser is intended for rehabilitation of the hands, fingers, and wrist disorders injuries and fractures. 453 Hand/finger splint Intended to immobilize an injured hand to protect from injuries to the digits, metacarpals, and wrist during the healing process. 454 Hand-carried stretcher Intended to carry patient as an assistance for injury or disability. 455 Handgrip cover for laryngoscope Intended to be placed over a reusable laryngoscope device during intubation to create a barrier in order to reduce the cleaning time and turnaround time of the laryngoscope blade for reuse. 456 Handgrip cover for surgical light Intended to provide physical barrier on a handgrip to prevent cross-contamination between the operating room surgical lights (non-sterile) and the operating room personnel. 457 Handgrip cover for vein illumination device The cover is intended to isolate vein illumination devices and simplify cleaning after use.

458 Hand-held dental retractor, reusable A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. This is a reusable device. 459 Hand-held surgical retractor, reusable A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery. This is a reusable device intended to be sterilized prior to use. It is intended for transient use. 460 Hand-held telescope Intended to enlarge images for a visually impaired patient/person. 461 Hand-held urinal, female, reusable Intended as a container/set to be directly urinated into by a female (typically bed-bound) patient for excretory purposes. This is a reusable device. 462 Hand-held urinal, male, reusable Intended as a container to be directly urinated into by a male (typically bed-bound) patient for excretory purposes. 463 Head marking cap A non-sterile head covering intended to be worn on the head of a patient to allow a healthcare professional to mark specific reference points on the head during a procedure [e.g., transcranial magnetic stimulation (TMS)] as an alternative to marking the scalp directly or to avoid cutting the patient’s hair.
464 Head reflector A head-worn device intended to reflect light to a site of examination/minor intervention (e.g., the nose, throat, or body surface) on a patient. 465 Head Rest/Ring Intended to position and protect a patient's head, face and neck during prolonged surgeries. 466 Heal cushion/Spur pad/cup Intended to be worn on the heel to relieve heel pain, plantar fascitis, foot pain, pain during walking, calcaneal spur, sprain and strain of the foot, ankle, feet and knee pain, etc. 467 Heat therapy gel A non-sterile gelatinous compound in a container that is intended to be applied to the body surface to provide a warming effect for underlying tissues. It is intended to reduce/relieve pain, muscle tension, and to increase local circulation.(Not intended for direct contact with tissue). 468 Heat-sealing device A device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.

469 Heel stirrup Intended to position and support the patient’s foot, lower leg and upper leg in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery.
470 Hip pad positioning device It is used to support the patient hip during prolonged surgeries.
471 Hip prosthesis socket pusher to hold an acetabular cup or shell at the distal end. It may be used to force the acetabular component of a total hip prosthesis into the proper position in the acetabular vault of the pelvis. This is a reusable device. 472 Hip protector (Belt) Intended to be worn by older adults or patients who have balance/vision problems, bone conditions, or at risk of falling to prevent hip injuries and fractures. 473 Hip shield A mechanical guard worn over the hip to reduce risk of injury in the case of a fall. 474 Hoof knife
A non-powered device intended to cut the hooves in animals such as cattle for purposes such as preventing mobility issues, and aiding in examination/treatment by a veterinarian, etc.
475 Hoof trimmer/puller A non-powered device intended to pull or trim the hooves of animals such as horses to aid a veterinarian during medical examination/treatment. 476 Hook, intrauterine device removal A hand-held manual instrument intended to be used by a physician for the extraction of an intrauterine device (IUD). This is a reusable device. 477 Hook, surgical, general- purpose intended for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not a blade-style retractor. This is a reusable device. Not intended for direct contact with central circulatory/central nervous system. 478 Hook, surgical, gynaecological, fibroid to fix or apply traction to uterine fibroids. This is a transient-use, reusable device intended for be sterilized prior to use. 479 Hook, surgical, rhinoplasty, reusable intended to be used in plastic surgery of the nose. This is a reusable device intended for transient use. 480 Hook, surgical, skin, reusable intended to fix or apply traction to the skin. This is a reusable device.

481 Hook, surgical, tendon/Soft- tissue surgical hook, reusable intended for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). This is a reusable device. Not intended for direct contact with central circulatory/central nervous system. 482 Hook, surgical, tracheal A manual surgical instrument intended to hold the trachea steady during the creation of a tracheostoma and/or for separating/drawing aside the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. This is a reusable device. 483 Horizontal non-powered traction system Intended to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae of patient by means of attached harnesses. This does not have a measuring function (or measuring graduations). 484 Hospital Backrest
Intended to support patients with spinal problems and pain management. 485 Hospital bed remote control (hand-operated/foot operated) Intended to control the operation and movement of hospital beds, operation tables, medical chairs/couches, etc. 486 Hospital Bedside cabinet A console by a patient's bed in a hospital/healthcare institution, that may contain storage shelves, open storage space, drawers, radio, and nurse/call units. 487 Hospital Linen trolley Intended to transport linen, that may or may not be soiled, from a patient ward to laundry and vice versa. Intended for hospital use. 488 Hot/cold therapy pack, reusable Intended for use to help relieve pain and reduce swelling caused by sprains, strains, insect bites, bumps and bruises, minor burns, tension headaches and muscle aches, stiffness, arthritis and cramps. 489 Hruby fundus lens Intended for use in the examination of the vitreous body and the fundus of the eye under slit lamp illumination and magnification. 490 Hydraulic/pneumatic external knee prosthesis This device is intended for transfemoral amputees to restore some function of an anatomical knee joint. 491 Hydrophilic wound dressing, non-sterile A non-sterile device intended to cover a superficial wound and to absorb exudate.

492 Hydrotherapy equipment/tank A component of hydrotherapy system intended for use during rehab treatment which includes resistance created by water to aid in injury recovery, improve blood circulation, and decrease inflammation, speeding recovery time. Other hydrotherapy equipment are not included. 493 Ice bag Intended to alleviate pain and/or promote healing in minor injuries of the body or for application around the neck or limbs. 494 ICU Bed, mechanical/electric Intended to be used as a patient bed in the intensive care unit of a hospital/health care facility, and which may be motorized providing the patient/nursing staff with ability to adjust the bed positioning or height. This does not have a measuring function. 495 Image display monitor mount A dedicated mount onto which a visual display unit (VDU), e.g., a patient monitor (not included), can be placed and secured so that it is safely mounted in a position suitable for viewing. It is manufactured for hospital use. 496 Incentive spirometer A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep- breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. This is not a diagnostic device. 497 Incontinence device suspender
A device intended to be used by a person with a disability to secure a body-worn incontinence device [e.g., a nappy (diaper) or a pad] in a stable and safe position. 498 Incontinence penis clamp, reusable Intended to gently compress the penis to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder. 499 Indirect binocular ophthalmoscope An ophthalmic instrument intended to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures. 500 Infant acoustic earmuffs, ENT A device intended to cover ears of neonates/infants to provide noise insulation in a special care unit.
501 Infant CPAP stabilizing cap/strap Intended for use as a stabilizing head strap/cap as an accessory of infant nasal CPAP respiratory support breathing system (CPAP system not included).

502 Infant heat loss prevention blanket/ Infant hypothermia prevention blanket, non- powered A non-invasive, non-powered device intended to cover an infant/neonate to prevent heat loss. This is a non-sterile device that may be reusable or single-use. 503 Infant incubator warming hood A non-powered cover-like device intended to be positioned above an infant incubator (not included) to retain warmth for the incubator environment. It does not have any additional functional uses.
504 Infant inguinal hernia truss Intended to be worn over the groin to prevent protrusion of abdominal contents in an infant with an inguinal hernia. 505 Infant limb immobilizer, reusable A non-sterile device intended to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. 506 Infant limb immobilizer, single- use A non-sterile device intended to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. 507 Infant oral pacifier
Intended to be used to calm the premature infant for longer duration specifically during nasal CPAP or when infant is intubated and on mechanical ventilation. For hospital use only. 508 Infant resuscitation cabinet A small chamber, that may be wall-mounted intended to serve as a support surface onto which an infant is placed for resuscitation. It does not include any resuscitation equipment (i.e. supplied empty). 509 Infant resuscitation table A flat surface on which newborn infants who do not breathe spontaneously at birth and are oxygen deficient are placed for emergency resuscitation. It does not include any resuscitation equipment (i.e. supplied empty). 510 Infant sleep positioner/ Infant positioning aid A non-powered device intended to modify the sleeping position/posture of infants to prevent deformational plagiocephaly, a flattening of the back of the skull from a consistent back-sleeping position. This is a reusable device. 511 Infant whole-body immobilizer, reusable A device intended to be used to temporarily render an infant's whole body immovable (strait- jacket effect) while the patient undergoes therapeutic or diagnostic interventions. This is a reusable device.

512 Infant whole-body immobilizer, single use A non-sterile, disposable device, intended to temporarily render an infant's whole body immovable (strait-jacket effect) while the patient undergoes therapeutic (e.g., phototherapy) or diagnostic interventions. This is a single-use device. 513 Infant-hammock bed mattress Intended to be placed in a cot/crib/bassinet/bed/ incubator (not included) and to cradle a young infant during sleep/rest. It may be used during phototherapy and transportation. Intended to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), pressure sores, and hyperthermia. 514 Infant-hammock bed mattress overlay Intended to be placed on a cot/crib/bed mattress and to cradle a young infant during sleep/rest to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), and hyperthermia. 515 Inflatable limb splint A non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize the limb. 516 Inflatable patient transfer sliding mattress An inflatable device intended to support a recumbent patient on a bed or table and assist in the physical movement of a patient for safer, easier transfer and positioning in Trendelenburg and Reverse Trendelenburg. 517 Infusion line clamp A non-sterile device intended for the clamping of medical tubes. 518 Infusion line securement clip, single-use The device is intended to hold tubing to avoid kinking of the tube during infusion and patient moving.
519 Inguinal hernia belt (Adult)/surgical truss, reusable A reusable device intended to relieve discomfort and hernia pain caused by an inguinal or sports hernia. 520 Inguinal hernia belt (Adult)/surgical truss, singe use A single use, non-sterile device intended to relieve discomfort and hernia pain caused by an inguinal or sports hernia. 521 Injection site desensitizer, tactile A non-sterile, noninvasive reusable device intended to be used to manually apply tactile pressure stimuli to a skin-surface injection site, prior to/during injection, to reduce the pain/anxiety/stress associated with injecting.
522 In-line backflow valve, reusable A general-purpose device intended to be used in medical tubing or pipelines to prevent the backflow of gases or liquids. This is a reusable device.

523 Instrument trolley, with/without tray/Mayo Instrument Trolley An open mobile cart intended to store and/or transport instruments for use during surgical and/or medical procedures within a hospital/health care facility.
524 Integration Unit for Flat panel x-ray detector
A portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a digital x-ray system (retrofit) using the same modality components. 525 Internal spinal fixation procedure kit, reusable A collection of various orthopaedic manual, non- measuring surgical instruments (screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill, etc.) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable 526 Intestinal ostomy base plate The base plate is intended to fix the ostomy bag and adhere to intact skin around the stoma. 527 Intestinal ostomy support kit A collection of non-sterile devices (base plate, towels, scissors) intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). 528 Intestinal stoma shield/support belt A non-sterile plate intended to be placed over an enteric stoma to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. 529 Intraoperative chest positioner A non-sterile, preformed reusable pad intended to be attached to an operating table for stabilizing a patient's chest (shoulders, pelvis, etc.) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures. This is a reusable device. 530 Intraoral camera Intended to capture high resolution image/video of intraoral anatomy as an assistive aid during management of dental/intraoral conditions (e.g., plaque, tartar, etc.) using light in visible/infrared spectrum only. It is not intended for diagnostic purposes and cannot connect to other high-risk active devices. This is a reusable device.

531 Intraoral Optical Scanning System, basic

OR

3D Oral Scanner A standalone device intended to create 3- dimensional (3D) digital impressions of a patient's oral cavity, including the structure of teeth and gums, by optical scanning (laser/LED in visible/near infrared spectrum), which may be further used for design and manufacturing of dental restorations and prosthesis. It does not have any additional features/intended purposes, and cannot connect to any high-risk active device. This does not have a diagnostic or measuring function. 532 Intraoral-scanning analog for dental implant abutment A non-sterile intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is not a permanent implant. 533 Intravenous access monitoring system, line- disconnection An alarm system intended to connect to sensors (not included) around/on a venous puncture site dressing or catheter connection to detect blood or disconnection of the catheter. 534 Intravenous catheter holder, non-sterile It is a skin adhesive device for the securement of urinary catheters and medical tubing as part of ongoing catheter care. 535 Intravenous hanger The device is intended to be used within the medical application to hold infusion bags within the approved load range.
536 Intubation laryngoscope, reusable A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. This is a reusable device intended to be sterilized prior to use. This device does not have any additional functional uses. 537 Intubation teeth protector A non-sterile device intended to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. 538 Inversion table, physiotherapy Intended to support the body of a patient and provide traction for the back muscles and spine by allowing the patient to manually invert their entire body in a supine position (feet up and head down), thereby assist in alleviating back pain.

539 Irrigation tip, surgical mist A non-sterile device that is intended to be connected to an air/water syringe to blow a mixture of air and/or water into a patient's mouth to clear debris during dental procedures.
540 Isolation gown, reusable A non-sterile garment intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a reusable garment. 541 Jaw exerciser, non-powered Intended to be used to exercise jaw muscles for temporomandibular disorders, increased saliva production, helping to improve efficient food chewing and swallowing. 542 Joint/spinal manipulator, mechanical, reusable A hand-held, non-electric, mechanically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable device. 543 Kidney tray/Cidex tray A device designed as a receptacle for vomit or oral secretions, typically from an immobile patient (e.g., one confined to bed, chair, or wheelchair). 544 Kinesiology tape Intended for use to support and relieve pain in muscles, joints, and/or ligaments. It may aid in reducing swelling, increasing mobility and enhancing recovery rate. 545 Kinetic bed Intended to enable continuous change of the patient's lying position. It does not have a measuring or therapeutic function. 546 Knee cap/brace/wrap Intended to limit the mobility of the knee to relieve pain in conditions of arthritic pain, ligament/muscle injury, surgical procedures, fractures, sprains, etc. 547 Knee ice wrap Intended to relieve pain, swelling and inflammation in the knee due to ACL, arthritis, sports injuries, sprains, strains, muscle fatigue and surgery. 548 Knife handle/ Scalpel handle, reusable A device intended to mount a compatible scalpel blade. This is a reusable device. 549 Knife sharpener A device intended to create or re-establish a thin, keen edge or fine point on an instrument used to cut during surgical procedures, such as a knife.

550 Lacrimal tube insertion hook/pusher, reusable A hand-held manual instrument intended for introducing a lacrimal tube/stent into the canaliculi, nasolacrimal duct, and/or nasal cavity through the corner of the eye, during a lacrimal intubation procedure for treating pathologies of the tear drainage system. This is a reusable device. 551 Laminar Air Flow/ Biosafety cabinet (BSL I) Designed as a partial or total enclosure to provide a class I biosafety level (BSL) to the operator and the environment during the manipulation of microorganisms and other biological hazardous materials. Intended for hospital/clinical lab use.
552 Laparoscope laser adaptor Intended to connect the laparoscope (not included) to the laser or the laser arm (not included) for laparoscopic laser treatment. 553 Laparoscopic surgery handle A manually operated handle of various configurations intended to hold instruments used in laparoscopic surgery. This is a reusable device. 554 Laparoscopic tray Intended for holding laparoscopy instruments during a laparoscopic intervention or sterilization. 555 Laryngeal airway introducer, reusable A non-sterile device intended to aid insertion of a laryngeal airway into the pharyngeal cavity of a patient while reducing or eliminating the need for finger manipulation within the mouth. This is a reusable device intended to be sterilized prior to use. 556 Laryngeal knife, reusable to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. This is a reusable device intended to be sterilized prior to use. 557 Laryngeal mirror, reusable A hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. 558 Laryngoscope blade, reusable A component of a laryngoscope (i.e., non- endoscopic rigid type) that is intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It may be MR- compatible. This is a reusable device.

559 Leg intraoperative repositioning support A mechanical device intended to be used to help support the weight of a patient's leg when the leg needs to be repositioned during an orthopaedic procedure. It is designed to be attached to the operating table. 560 Lens system, Ophthalmology, high magnification A device (lens) intended for use to observe the retina or anterior chamber of the eye. 561 Lifting column with/without control box A device in its finished form, specifically designed and intended to control the movement of electric medical beds, examination tables, patient lifts, etc.
562 Ligament reconstruction instrument set, reusable A collection of hand-held, manual, non- measuring surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It may consist of drill bits, reamers, burs, pushers, introducers, impactor, surgical hammer, etc. This is a reusable device intended to be sterilized prior to use. 563 Light beam patient position indicator Intended to project a beam of light (incoherent
light or laser) to determine the alignment of the patient with a radiation beam. 564 Limb/torso/head restraint, reusable It is intended to position and support patients in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery during Reverse Trendelenburg positioning.
565 Liquid crystal vein locator Intended to indicate the location of a vein by revealing variations in the surface temperature of the skin. 566 Lower limb exerciser, non- measuring Intended to provide above and below knee amputees the ability to improve muscle and strengthen residual limbs. This does not have a measuring function. 567 Lower limb sliding exerciser, non-powered A non-powered device intended to encourage active movement of a patient’s lower limb(s) by assisting flexion/extension at the knee for rehabilitation. This is a reusable device. 568 Lower-limb orthosis The device is an externally-applied wearable appliance intended to support and correct deformities of the leg and/or feet. This is a single- patient reusable device. 569 Lower-limb warming sock/stocking Intended to be worn on the feet and/or legs of a patient to minimize loss of body heat during surgeries, treatment, birthing, or general hospitalization.

570 Maddox trial lens A device intended to change the size, shape, and colour of an image to dissociate the eyes during the evaluation of eye muscle dysfunction. 571 Magnetic field shielding material for cochlear implants
An accessory intended to be used on Cochlear implant recipients to prevent implant magnet dislodgement during MRI scans. The device is placed externally on the recipient's head by a healthcare professional prior to undergoing an MRI procedure. 572 Mammographic x-ray phantom, test object A device intended to be used as a quality assurance device in evaluation of various calibration and performance characteristics of dedicated digital or conventional diagnostic x-ray mammography systems or general-purpose x-ray systems adaptable for mammography applications. This is not a measuring device. 573 Mammographic x-ray system compression paddle A mechanically, electronically or software- controlled component of a mammographic x-ray system intended to flatten and stabilize the breast during mammography studies or mammography system-guided biopsy procedures.
574 Mandible-repositioning sleep-disordered breathing/ Anti-snoring orthosis A removable intraoral device intended to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. This is a reusable device. 575 Mandible-repositioning/ palate-lifting sleep- disordered breathing/ Anti- snoring orthosis A removable intraoral device intended to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning the lower jaw (mandible), frequently in a downward and forward position, and by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). This is a reusable device. 576 Manual dental burnisher, reusable Intended to polish the surface and smooth the margins of restorations during dental procedures. 577 Manual dental torque wrench, reusable A hand-held device intended to be used to manually tighten dental implants and/or retaining screws fitted into the oral cavity during a dental surgical procedure. This is a reusable, non- measuring device.

578 Manual dexterity assessment software The software is intended to detect micrographia (smallness of writing), bradykinesia (slowness of movement) and tremor with the help of an off-the-shelf tablet and a digital pen. This is not intended for self-assessment. This does not have a measuring function or AI- integrated features. 579 Manual dexterity test Dexterity devices intended to evaluate motor coordination, depth perception and eye-hand coordination in a subjective manner. This does not have AI--integrated or measuring function. 580 Manual endodontic filling material spreader A hand-held, manually-operated dental instrument specifically intended to compress filling materials in a root canal, mainly in a lateral direction. This is a reusable device. 581 Manual general-purpose hospital bed Intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. This does not have a therapeutic function. 582 Manual non-rotary dental instrument handle A hand-held, manual device intended to hold and facilitate manipulation of a non-powered, non- rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is intended to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device. 583 Manual orthopaedic bender, reusable A manually-operated surgical instrument intended to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. This is not intended for direct on-patient use. This is a reusable device.
584 Manual orthopedic cement extractor, reusable to extract orthopaedic (bone) cement from a site of previous application during an orthopaedic surgical procedure to replace a previously cemented prosthesis. This is a reusable device for transient use. 585 Manual patient lifting belt/harness A device intended to assist healthcare professionals or attending persons to physically move and lift a patient or a person with a disability (e.g., from the floor to a bed). This is a reusable device. 586 Manual scalpel blade, reusable A surgical instrument intended to mount a compatible handle and function as the cutting edge of a scalpel for manually cutting and dissecting tissues. This is a reusable device.

587 Manual stander A manually-powered, mobile device intended to support and lift a disabled patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is not intended to facilitate gait. 588 Manual toothbrush An instrument intended to be used by a patient to manually brush clean their teeth and gums for removing plaque, tartar, etc. and/or aid in prevention of dental disorders such as caries. 589 Manual wheeled stretcher Intended to transport patients in a horizontal position as an assistance to injury or disability. 590 Manual-aperture-control diagnostic x-ray system collimator, non-motorized A standard, non-motorized, diagnostic x-ray beam-limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x-ray cassette in use.
591 Marker, dental use This device range helps mark plaque areas on a tooth and is thus intended to be used to aid disclose/make marks that allows identify dental plaque. 592 Mask strap A head strap intended to hold and stabilise a CPAP or BiPAP face mask onto a patient's face. 593 Massage table/couch Intended for supporting body during therapeutic massages (not intended for general wellness purpose). 594 Mastoid chisel, reusable intended to cut and shape the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) during ear/nose/throat (ENT) surgery. This is a reusable device. 595 Maternity belt
It is used to support the belly bump during the different prenatal periods to avoid forward and downwards stomach pulling, provide maximum support and relieve back & pelvic ache.
596 Maternity pad A specially-designed, externally worn, absobent pad to absorb postpartum bleeding and vaginal discharge that occurs after childbirth (lochia). This is a single-use device. 597 Mattress for hospital bed Intended to be placed over a hospital bed for supporting a patient while resting. Intended for hospital use. 598 Mechanical dental chair without operative unit Intended to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It does not include operative unit.

599 Mechanical positive pressure airway secretion clearing device A hand-held, mechanical device intended to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease. It is not intended to connect to high risk active medical devices. This is not a measuring device. 600 Mechanical-resistance external ankle-foot prosthesis External prosthetic components for the purpose of replacement for a foot/ankle. The foot/ankle is intended to be used for a lower limb external prosthetic system. 601 Mechanical-resistance external knee prosthesis An externally applied component intended for use in replacement of the knee joint (or other) in persons with limb amputation or difference.
602 Mechatronic external ankle- foot prosthesis A battery-powered device intended for use as part of an external prosthetic system that replaces the foot and ankle function of a missing lower limb. 603 Medical bowl
A general-purpose, non-sterile bowl or basin intended for medical purposes such as containing fluids, carrying or holding instruments prior to or during a surgical procedure, and collecting body waste or other matter for disposal. This is a reusable device. 604 Medical compression stockings Intended for management/prophylaxis of leg pain, deep vein thrombosis, varicose veins and related complications 605 Medical Equipment/instrument drape, reusable A noninvasive protective barrier intended to cover and protect the equipment/instrument from soiling and/or contamination. This is not a dedicated cap or cover, or a transducer cover. This is reusable. 606 Medical Equipment/instrument drape, single-use, non-sterile A disposable, noninvasive protective barrier intended to cover and protect the equipment/instrument from soiling and/or contamination. This is not a dedicated cap or cover, or a transducer cover.
607 Medical examination gloves, latex/non latex, non-sterile Intended to be worn by medical personnel during medical examinations to protect the patient and users from cross infection during examination, check-up, and handling of contaminated medical materials except for surgery. 608 Medical examination light (AC powered or Battery) Intended to illuminate body surfaces and cavities during a medical examination. 609 Medical image printer A non-invasive, reusable printer that produces hard copies of medical video images.

610 Medical image storage device Intended to provide electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. 611 Medical imaging recorder
A non-invasive, reusable electrically powered device intended to be used in conjunction with video endoscopes, and/or surgical video imaging devices to digitally record video images. 612 Medical Instrument cabinet Intended to store surgical instruments and equipment in a hospital/health care facility. 613 Medical instrument cable/lead A reusable cable intended for use as a conductor between power source and the medical instrument used for the purpose of transmitting an energy that may, or may not, contain information. 614 Medical instrument lubricant Intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument). 615 Medical Laser protection/safety eyewear Intended to be used by the staff in an operating or treatment room where a laser is being used, in order to protect their eyes from injury during the laser surgery. 616 Medical print paper
Thermal, non-gridlined paper intended to be used to produce hard copy of printed data generated by a medical device. For recording the EEG,ECG, EMG output from the ECT device. 617 Medical support stocking Intended to be worn on the upper or lower extremity to support, correct, prevent deformity, or to align body structures for functional improvement. 618 Medical x-ray film, non- screen A non-screen x-ray film intended for use in medical imaging applications. Non-screen x-ray film is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens. 619 Medical/cadaver body bags, non sterile Intended for transporting a human corpse without any spread of biohazard/infectious agent. 620 Medical/Orthotic insoles Intended to be worn inside shoes/footwear to relieve heel pain, plantar fasciitis, foot pain, pain during walking, calcaneal spur, sprain and strain of the foot, ankle, feet and knee pain.

621 Medicine chamber spacer A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. 622 Medicine cup A specially designed cup intended to be used by the nursing staff to administer tablets or pills to patients. It may be used both for tablets and fluids. It does not have measuring function. 623 Medicine trolley Intended to store and transport medications within a hospital/health care facility. This does not include any medications. 624 Meibomian gland camera It is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands. 625 Meibomian gland expressor/evaluator, manual A non-powered, hand-held manual ophthalmic instrument intended to be used to apply pressure to the lower eyelid to facilitate natural release and/or expression of meibomian gland secretions (meibum) to treat dry eye syndrome.
626 Metatarsal pad Intended to relieve chronic metatarsal pain, corns, hard skin, morton’s neuroma, forefoot soreness, and painful balls of the feet. 627 Microporous medical tape Intended for dressing retention on non-flexing areas and may also be used for patients who have exhibited an adverse reaction to adhesives based upon zinc oxide, rubber, or resin. This is not intended for use as a surgical/wound dressing. 628 Microscope cover This is a device which is usually shaped to fit the surgical camera/microscope that is intended to be used as a physical barrier to prevent cross- contamination between staff or patients during examination. 629 Middle ear chisel, reusable A hand-held surgical instrument intended for manually cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. This is a reusable device. 630 Middle ear malleus nipper/ hook/anvil, reusable to be used to cut the malleus (hammer-shaped lateral bone in the middle ear). This is a reusable 631 Middle ear pick, reusable A fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). This is a reusable device intended for transient use.

632 Mirror-prism spectacles Intended to enable the patient to see over the top of their head enabling them to look forward in the direction their head is pointing. 633 Mobile patient lifting system, electric An electrically-powered, mobile assembly of devices intended to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom. 634 Mobile patient lifting system, manual A non-powered, mobile assembly of devices intended to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom. 635 Mobile radiation protection barrier Intended to protect the operator etc. from unnecessary exposure to radiation used for medical diagnosis, treatment and dental procedures. 636 Moist-cold pack A non-sterile device intended to be temporarily applied to a particular area of the body surface to provide moist cold for purposes such as reduction in inflammation, control bleeding, relief in discomfort due to fever, etc. 637 Moist-cold pressure bandage A pressure bandage intended to provide a cool
environment and to compress a local area of the body.Intended for intact skin. 638 Moldable splint A moldable splint device that is intended for use as an immobilization of non- or minimally displaced wrist fractures, contusions, and sprains.
639 Mortuary trolley, mechanical/hydraulic/electric A wheeled table or stretcher used to transport a corpse from the morgue's refrigerator to the work area or to transport a corpse from a hospital room to the morgue. 640 Motorized diagnostic imaging view box Intended to retain, retrieve, and project light for direct observation of medical images taken using a variety of methods such as X‐ray, magnetic resonance (MR), CT, and ultrasound, and recorded in radiographic film. 641 Mouth gag To be used in dentistry to be placed between the teeth of a patient in order to maintain an open oral cavity during dental procedures. 642 Mouth speculum/ Mouth gag (for veterinary use) Intended to keep the mouth open during oral examination, intubation, etc. This is a reusable device.

643 MRI enhancement padding Dielectric pads that are intended for use with magnetic resonance imaging systems to aid in body positioning and help reduce shading artifacts associated with the air/tissue interface during abdominal, pelvic, and neck imaging. 644 MRI examination catheter holder The device is intended to be used with ICP catheter kits to enable the catheters to be left in during MRI scanning. 645 MRI phantom, test object Intended for used during evaluations of various calibration and performance characteristics of magnetic resonance imaging systems and associated image acquisition, display, and analysis computer programs. 646 MRI system chair A chair or stool specifically designed and intended to support and position a patient during examinations involving the use of a diagnostic magnetic resonance imaging (MRI) system. For MRI system compatibility these chairs/stools are made of ferromagnetically inactive materials. 647 Multi-chamber venous compression system garment A garment intended for use with a compression system (not included) in preventing deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. 648 Multi-modality therapeutic radiation phantom, test object This device is intended to establish and provide for routine and periodic verification with use of target motion of patient dose and machine output in therapeutic radiation oncology system performance. 649 Multiple spinal region orthosis This is a body-worn device that is intended to provide full circumferential containment when reduction in gross spinal motion about the lower thoracic and lumbar spine is required. This may include post operative spinal stabilisation, fracture and related soft tissue injuries. 650 Nail splitting scissors, reusable A surgical instrument intended for the purpose of cutting and splitting a finger or toenail, typically for removal, during a surgical intervention. This is a reusable device. 651 Nappy changing table, portable Intended to support an infant, child or an adult during nappy (diaper) changing, or for a patient with a disability who is incontinent and requires regular changing of their nappies. Intended for use in hospital/clinical environments. 652 Nasal aspirator, electric Intended for superficial use to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing.

653 Nasal aspirator, manual A portable, hand-held, manual suction device intended to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. 654 Nasal chisel, reusable A hand-held surgical instrument intended for manually cutting or shaping nasal bones, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. This is a reusable device. 655 Nasal dilator Intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. Not intended for long-term use. 656 Nasal Irrigation kit A collection of non-sterile instruments intended to cleanse or flush the nasal passages and sinus cavity with saline for postoperative, preventive, or symptomatic nasal care.
657 Nasal irrigation kit, pediatric A collection of non-sterile instruments intended to irrigate the nasal passages of infants and young children. 658 Nasal scissors, reusable A hand-held, manual, surgical instrument used to cut tissue during ear/nose/throat (ENT) or plastic surgery in or on the nose and its associated structures. This is a transient-use reusable 659 Nasal septum straightening forceps Intended to straighten the nasal septum through grasping and manipulation of the bone/cartilage of the septum during nasal reconstructive procedures. This is a reusable device. 660 Nasal speculum, reusable A hand-held surgical instrument intended to be inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. This is a reusable device. 661 Nasogastric tube holder, intranasal, short-term use A non-sterile, non-surgically invasive, device intended to be used with enteral feeding tubes to prevent inadvertent removal or displacement of the tubes for adult patients. Not intended for long- term use. 662 Nasogastric tube holder, non-sterile
This device is intended to secure nasogastric tubes to skin near and around the nose. 663 Needle guard Intended to encapsulate needles withrawn from vein or fistula thereby aiding in the prevention of needle stick injuries.

664 Needle holder, ophthalmology, reusable It is intended to hold needle for procedure during eye surgeries. This is a reusable device intended to be sterilized prior to use. 665 Needle/Syringe cutter A device intended for use in hospitals and other health care settings to cut a syringe needle to prevent its reuse. This is a reusable device. 666 Neonatal eye pad Used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy. 667 Neonatal kangaroo care garment A non-sterile, upper body garment intended to allow a parent to safely carry/support their premature, dysmature, and/or sick infant in a manner which enables skin-to-skin contact between parent and infant (kangaroo care). This 668 Nerve/vessel retractor/hook, reusable A hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. This is a reusable device intended for transient use. 669 Neuro Pinwheel A non-invasive, non-powered device intended for testing pain sensation. 670 Neurosurgical chair Intended to support and position a patient in a sitting or reclined position during neurosurgery. This does not have any measuring or therapeutic functions. 671 Neurosurgical headrests Intended to support the patient's head during a surgical procedure 672 Newborn-infant bed Intended as support surface to newborn babies. 673 Nipple pad/ring, reusable A device intended to be worn directly over the breast/nipple of a nursing woman between breast feedings to help protect the nipple from chafing, due to friction from clothing, and/or to treat sore/cracked nipples; it may also be intended to absorb leaking breast milk. 674 Nipple prosthesis, external An artificial replacement for a female breast nipple that is applied to an external breast prosthesis for a mastectomized woman. This is a reusable device. 675 Nipple shield Intended to aid infants with trouble latching onto the breast by acting like a longer, firmer nipple. 676 Non-antimicrobial postsurgical brassiere Intended to support and/or contour the breast(s) or hold a dressing in place after surgical intervention (e.g. thoracic surgery, mastectomy, lumpectomy). May be used to prevent the formation of oedema and to support venous return and lymphatic drainage.

677 Non-antimicrobial postsurgical female underpants It is intended for use during medical treatment (e.g., chemotherapy) or be used to protect the skin following treatment with a medication (e.g. ointment, cream). 678 Non-powered accelerator system table Intended to adjust the patient's posture and immobilize the patient for radiotherapy. 679 Nonpowered flotation therapy mattress Intended for use with a pump (not included) for medical purposes which contains air, fluid, or other materials, to treat or prevent decubitus ulcers (bed sores). 680 Non-powered neutron therapy table Intended to adjust the patient's posture and
immobilize the patient for treatment that uses neutron rays. 681 Non-powered remote irradiation therapy table Intended to adjust the patient's posture and
immobilize the patient for treatment that uses a remote radionuclide radiotherapy apparatus (not included). 682 Non-powered X-rays radiation therapy table Intended to adjust the patient's posture and
immobilize the patient for treatment using X- ray radiation therapy. 683 Non-sterile Hemostatic clip applier A reusable surgical device intended to apply a hemostatic clip (not included) for ligation of a blood vessel. 684 Nose clip An accessory of spirometer intended to prevent air movement through the nose during pulmonary function tests. 685 Nose clip (Spirometry accessory) Intended to plug nostrils during spirometric analysis
686 Nuclear scanning bed/table A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedures. This does not have any measuring or therapeutic functions. 687 Nuclear sealed calibration source A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors. 688 Nystagmus inducing optokinetic drum Intended to elicit nystagmus. 689 Nystagmus inducing tape Intended to be moved across a patient's field of vision to elicit optokinetic nystagmus and to test for blindness. 690 One-piece urostomy bag, non-sterile The ostomy bag is intended to collect output from a stoma. The adhesive is intended to fix the bag and adhere to intact skin around the stoma.

691 One-piece urostomy bag, open-ended, non-sterile A one-piece plastic pouch intended to be attached to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended).
692 OPD Patient couch/chair A seat, that may be height-adjustable, intended to be occupied by patients during medical procedures, examinations, or rest; it may include support for the back, arms and feet (footrest/ring). 693 Operating room shoes cover, non-sterile Intended to be worn by operating room personnel during surgical procedures to protect foot of both the surgical patient and the operating room personnel from transfer of micro-organisms, body fluids, and particulate material. 694 Operating table traction frame Intended to position, support and/or distract the patient’s hand, wrist, forearm and arm in a variety of surgical procedures including, but not limited to arthroscopic or Orthopedic surgery.
695 Operation theatre pendant Intended to provide ergonomic solution for the positioning and management of medical devices, equipment, and utilities during surgeries and other medical interventions. It does not have additional functional uses. 696 Operator radiation protection spectacles Intended to protect the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment. 697 Ophthalmic equipment stand It is intended to hold and support ophthalmic equipment like slit lamp, keratometer, laser devices, etc. Ophthalmic instruments are not included. 698 Ophthalmic head reflector Intended to reflect light onto the eye of a patient to allow examination of the eye and its associated structures. 699 Ophthalmic implant handling forceps, reusable A reusable instrument intended to grasp and manipulate ophthalmic implants (excluding sutures) during a surgical procedure. 700 Ophthalmic operating table top Intended to provide support for and stabilization of the head of the patient and to help provide optimal access for the surgeon(s) during the intervention. 701 Ophthalmic surgery fluid collection bag A fluid collection bag connected to a surgical system (not included), intended to catch aspirated material during an ophthalmic surgical procedure.

702 Ophthalmic surgical device handling forceps, reusable Intended to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor). This is a reusable device. 703 Ophthalmic suture scissors, reusable A hand-held, manual ophthalmic surgical instrument intended to cut suture, typically during eye surgery. This is a reusable device. It is not intended to come in direct contact with the eyeball. This is a reusable device. 704 Ophthalmic Trial frame A device intended for use in ophthalmic work for holding trial lenses in front of the eyes during the sight-testing procedure. 705 Ophthalmoleukoscope Intended for testing colour perception by means of colours produced by polarized light. 706 Opthalmic examintaion station, without surgical unit A device assembly intended to provide complete ophthalmic examination position and support conditions for the patient and clinician. This does not include any diagnostic/surgical instruments. 707 Oral care swab A foam-headed oral swab impregnated with a sodium bicarbonate cleaning solution intended to be used wet to clean the teeth and oral cavity. 708 Oral exerciser, Physiotherapy A non-powered device that is intended to exercise tongue muscles as part of oral myology physiotherapy. 709 Orbital depressor, reusable A hand-held ophthalmic instrument intended to be used for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. 710 Oropharyngeal airway, reusable Intended to be inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a reusable device. 711 Orthodontic aligner/retainer seater A non-sterile device intended to aid in positioning and seating an orthodontic progressive aligner or teeth retainer into place. This is a reusable device intended for single-patient use. 712 Orthodontic band pusher A hand-held dental instrument intended for positioning and adapting metal bands on teeth in orthodontics. 713 Orthodontic elastomeric appliance pusher A hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. This is a reusable device. This is not an implantable device.

714 Orthodontic metal band pusher A hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device. This is not an implantable device. 715 Orthodontic positioner support kit A collection of devices intended to be used to facilitate use of an orthodontic teeth positioner, including placement, removal and cleaning. It typically consists of an orthodontic appliance remover, an orthodontic positioner seater, and an orthodontic appliance cleanser. The positioner is not included. This does not contain dental implants/medicated products. 716 Orthodontic resin positioning tray A custom-made dental device in the form of a patient’s dentition which contains cavities intended to hold and facilitate positioning of light- cured dental resin onto teeth for subsequent attachment of an orthodontic appliance (e.g. aligner) after curing.
717 Orthodontic vibrator Orthodontic predictability enhancement device intended to maximise the accuracy of fit and effectiveness of clear aligner treatment. 718 Orthopaedic bone pin holder A non-sterile device intended to temporarily hold one or more orthopaedic pins (e.g K-Wires) during sterilisation and surgical procedures to prevent damage.
719 Orthopaedic bone-fragment manipulator, reusable to help position a fractured fragment of bone to achieve proper alignment (reduction). This is a reusable, non-measuring device intended for transient use. 720 Orthopaedic bone-reduction tool, reusable to help reposition a fracture where two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. This is a transient-use, reusable device. 721 Orthopaedic broach, reusable A manual surgical instrument intended for shaping and enlarging holes in bone tissue. This 722 Orthopaedic chisel blade, reusable An interchangeable component of an orthopaedic chisel that is intended to function as the cutting blade for cutting or contour bone. This is a reusable device for transient use.
723 Orthopaedic chisel, reusable intended to cut and shape bone during orthopaedic surgery. This is a reusable device.

724 Orthopaedic fixation forceps, reusable to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. This is a reusable device. 725 Orthopaedic fixation plate tensioner, reusable to apply tension to an orthopaedic implant (typically a fixation plate) to compress a fracture site prior to final fixation of the implant. This is a reusable device. 726 Orthopaedic implant driver, reusable to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. (implants not included). This is a reusable 727 Orthopaedic implant impactor, reusable to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. This is a reusable, non-measuring device. 728 Orthopaedic implantable- device cutter, reusable A manual, hand-held or table-mounted surgical instrument intended to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). This is a reusable device. 729 Orthopaedic instrument extractor, reusable intended to extract another orthopaedic instrument from a patient's body during an orthopaedic surgical procedure. This is a reusable device. 730 Orthopaedic joint/limb rongeur, reusable to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. This is a reusable device. 731 Orthopaedic osteotome blade, reusable A sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. This is a reusable, non-measuring device. 732 Orthopaedic osteotome, reusable A chisel-like, manual surgical instrument intended to cut and/or shape bone by percussion during an orthopaedic procedure. This is a reusable, non- measuring device.

733 Orthopaedic prosthesis implantation positioning instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer- assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide, etc.]. It may be inserted into a bone for a transient duration. This is a reusable device intended for transient use. 734 Orthopaedic traction bed Intended to provide support for skeletal traction to stabilize fracture sites. This does not have a measuring function or diagnostic sensors. 735 Orthopedic cast padding It is intended to protect long prominences under the plaster on intact skin . 736 Orthopedic implantation sleeve, reusable A hand-held, surgical device intended to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not intended to place, angle, and guide a rotating surgical drill. This is a reusable device. 737 Orthopedic Reamer handle, reusable A hand-held reusable surgical device that is intended to be attached to the proximal end of an orthopaedic reamer shaft to allow the operator to manually rotate the cutting device. 738 Orthopedic Reamer, reusable A manual orthopaedic surgical instrument intended to open and enlarge the medullary canal for the insertion of various devices during prosthesis implantation or fracture fixation procedures. This is a reusable, transient use device. 739 Orthopedic rod reducer/cutter, reusable A hand-held manual instrument intended to reduce or seat a rod into the saddle of screws, hooks or similar devices during a surgical procedure. This is a reusable device. This does not include any implantable devices. 740 Orthopedic Spatula, reusable A hand-held manual surgical instrument intended to spread a material on a surface, to fill material into a cavity, manipulate tissue or to remove a material from a surface or a vessel. This is a reusable device.

741 Orthopedic walker shoes/boots/Air cast boots Intended for the treatment and rehabilitation of foot and ankle injuries and to provide support, stability, and protection to the foot and ankle during the healing process in cases of fractures, sprains, post-surgery, or severe foot or ankle injuries. 742 Ostomy adhesive Adhesive to be placed around stoma to attach two-piece ostomy collection device. 743 Otoscope cover, non-sterile A device intended to fit onto and cover an otoscope to form a physical barrier protecting patients against cross contamination. 744 Otoscope, direct Intended for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening.
745 Oxygen administration hood Intended to be used as an enclosure over the patient's head in order to provide an enriched oxygen (O2) environment to increase the patient's O2 uptake. This does not include sensors and other active devices. 746 Oxygen administration hood, paediatric Intended to be used as an enclosure over an infant's whole body, or the head only, in order to provide an enriched environment of oxygen (O2) to increase the patient's O2 uptake. This does not include sensors and other active devices. 747 Oxygen administration tent, neonatal/paediatric Intended to cover the bed of a neonatal or small child to provide an enriched environment of oxygen (O2) to increase the patient's O2 uptake.
It is used for the treatment of breathing disorders in infant and paediatric patients permitting them movement without restriction. 748 Oxygen mask respiration indicator Intended to be attached to the exhalation vent hole on the exterior of a standard oxygen face mask and provide visual (qualitative) indication of patient respiration. It does not have measuring function. 749 Pacemaker test magnet Intended to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation. 750 Packer, gauze To be used in dentistry and dental surgery for introducing and packing gauze or dressings into cavities. 751 Paediatric bed A bed intended to be used to house children
(typically up to 12 years of age) that incorporates safety canopy tops, fixed endrails, and moveable and latchable siderails, minimizing the risk of falling out and allowing staff access. It is not intended for neonates/infants. Intended for hospital use.

752 Paediatric dental chair, electric without operative unit A powered, adjustable device solely intended to support a paediatric patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. Dental examination/treatment devices are not included. 753 Paediatric dental chair, mechanical without operative unit A manually- or hydraulically-powered, adjustable device solely intended to support a paediatric patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. Dental examination/treatment devices are not included. 754 Paediatric dorsiflexion slant board It is intended to therapeutically stretch the ankle plantar flexion muscles/tendons for the treatment of various medical conditions (e.g., congenital, neurological, post-traumatic) where tendon tightness and muscle contracture affect the ability to dorsiflex the foot, possibly leading to an abnormal gait. 755 Panniculus skin-adhesive retractor, reusable This retractor is intended to be used on intact skin for positioning redundant tissue (i.e., post c- section, post laparotomy) away from the lower abdominal incision/wound. 756 Parallel bar exerciser A non-powered device intended to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It does not have a measuring function. 757 Parapodium walking frame Intended to encompasse and provide support for the body of a patient who is unable to stand unassisted to help them move (walk) by changing their centre of gravity (COG). 758 Partial hand radiation protector Intended to protect part of hands and fingers from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. 759 Patient anatomy model for surgical planning A model of the bone of a specific patient intended for use to facilitate accurate preoperative planning and introperative placement of a device during orthopaedic surgical procedures. 760 Patient audiovisual communication system It is intended for use by trained personnel in functional, interventional and clinical MRI environments to facilitate audio communications during a scanning session.

761 Patient enclosure system A freestanding, framed, tent-like structure intended to be constructed on-site to function as a temporary enclosure to provide low-stimulation environment for safe playing, resting or sleeping, typically for a patient with autism, epilepsy, challenging behaviours and/or learning difficulties.
762 Patient examination chair/stool/couch A seat, which may be height-adjustable, intended to be occupied by patients during medical procedures, examinations, or rest; it may include support for the back, arms and feet (footrest/ring). Intended for hospital use. 763 Patient gown, non-sterile Intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office).
764 Patient holder The device is intended to support the trunk and/or lower limbs of a person with disabilities into a more symmetrical position, thereby preventing secondary complications such as joint contractures, pressure areas and pain.
765 Patient isolation tent canopy A non-sterile covering intended to be used with a frame to provide environmental isolation of a contagious patient to protect hospital personnel and other patients from exposure to non-airborne infections (e.g. diphtheria, meningococcus) whilst the patient is being treated. 766 Patient lifting system stretcher A lifting device used together with a patient lifting system (not included) to provide a support for an incapacitated patient or a person with a disability that is being lifted in a lying (horizontal) position for transfer and (re)positioning. 767 Patient transfer board Intended to reduce the friction and difficulty during the task of moving or transferring a patient from a surface to another, e.g., Bed to stretcher and reduce risks associated with manual handling by the staff. 768 Pedal exerciser A non-powered device intended for exercise therapy for upper and/or lower body. This is a non-measuring device. 769 Pediatric gait trainer A non-powered device designed as a frame with legs, intended to assist and train children unable to walk or stand independently to enhance movement and independent ambulation.

770 Pelvic floor exercise biofeedback device It is intended to facilitate regular pelvic floor exercises for strengthening of the pelvic floor muscles and rehabilitation and training of weak pelvic floor muscle. This may aid in treatment of urinary incontinence, improving function in individuals with existing pelvic floor dysfunction, improving pelvic floor function in the post-partum period and/or improving mild to moderate prolapse symptoms. This does not estimate/quantify muscle contraction forces and does not have any other measuring function. 771 Pelvic floor exerciser, male A manual, non-powered, non-sterile device intended to provide assistance for pelvic floor muscle exercises to adult males suffering from Intravaginal ejaculation disorders, such as premature ejaculation, etc.
772 Pelvic traction kit (with/without weights) A set of non-powered equipment intended to apply uniform and controlled traction to the lumbar, sacral, and thoracic areas of the vertebral column. It does not have a measuring function (or measuring graduations). 773 Percussion hammer, manual/ Manual percussor Intended to be used by an examining physician to gently tap near a patient's joints to test reflexes. 774 Periodontal curette, reusable A hand-held dental instrument intended to be used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. This 775 Periodontal knife/Gingivectomy knife, reusable A hand-held dental instrument intended to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). This is a reusable device intended for transient use. 776 Periodontic hoe, reusable A hand-held manual dental instrument intended to be used with a pulling action to remove gross amounts of supragingival calculus, and some subgingival calculus, in large wide-open pockets where the gingival tissue is soft and easily cleaned. This is a reusable device. 777 Periotome, reusable A hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. This is a reusable device intended for transient use.

778 Philadelphia collar (cervical) Intended to be used in cervical fracture to support neck bones and ligaments by restricting the movement of the neck muscles 779 Phoropter arm Intended to mount the phoroptor during an ophthalmic examination; typically to mount the phoroptor to determine a patient's prescription for glasses. 780 Phototherapy eye protector, reusable Intended to cover and protect the eyes of a patient or user from potentially harmful rays [e.g., ultraviolet (UV)] to which parts, or all, of their body is intentionally exposed during light therapy treatment. 781 Phototherapy eye protector, single-use A non-sterile device intended to cover and protect the eyes of a patient from potentially harmful rays [e.g., ultraviolet (UV)] to which their body is intentionally exposed during light therapy treatment. 782 Phototherapy infant blanket A piece of fabric, made from ultraviolet (UV) light transmittable material, intended to be used to wrap a newborn/infant during UV phototherapy for the treatment of neonatal jaundice (neonatal hyperbilirubinemia) to enable therapeutic light to pass through to the patient while simultaneously providing comfort. This does not have a therapeutic function. 783 Physical therapy table, line powered Intended to facilitate functional training of patients/subjects with loss of lower extremity, upper extremity or core functionality, caused by conditions of orthopedic, musculoskeletal, neurological, or other origin by providing muscular load in combination with visual feedback.
784 Plaster instruments/plaster saw An instrument intended to cut or shave or put
plaster. 785 Plaster of Paris bandage It is intended for support of fractured body part. 786 Plaster spreader Intended to separate and spread hardened plaster. 787 Plastic surgery osteotome, reusable intended to cut and/or shape small bones and/or cartilage during plastic surgery. This is a non-measuring, reusable device intended to be sterilized prior to use. 788 Pleoptophor Intended for use during the treatment of eccentric eye fixation (casts in the eye) by dazzling the perimacular retina, thereby relatively enhancing the visual capabilities of the fovea.

789 Pneumatic external knee joint Intended to replace knee joint in persons with lower limb amputation and connecting to above knee prosthesis 790 Pneumatic stander Intended to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, digestion, and flexibility); it is not intended to facilitate gait. 791 Pneumatic walker boot A boot-like wearable non-powered device intended to provide pneumatic compression and support to the ankle joint. 792 Polatest Intended for evaluating hidden (latent) squinting, i.e., when the patient is not aware of the condition, and also when it cannot be seen. 793 Portable system mount Intended to be fixed vertically within a clinical setting to enable the easy and secure mounting of a portable medical device. 794 Positioning aid system, assistive A dedicated mattress system intended for the disabled person allowing various positions to be maintained with the aid of positioning aids. It may also be designed to allow air flow to reduce sweating/heat and therefore the possibility of spasm. It is not a therapeutic device. 795 Postpartum maternity belt It is intended to help reduce swelling, provide support to the lower back and abdominal muscles, and promote healing after delivery. 796 Postsurgical head/neck garment It is a wearable contoured cranial cover intended for the restoration or augmentation of cosmetic appearance in patients with bony defects of the cranium. 797 Postsurgical transparent eye shield, vented A device intended to be worn over the eye to protect the eye while allowing the wearer to see, typically following ophthalmic surgery. It is designed as a transparent self-adhesive dome which includes vent holes to allow air to circulate around the eye. This is a single-use, non-sterile device. 798 Power wheelchair
Intended to aid in mobility of individuals with physical disability, lack of senses in lower extremities and having difficulty in walking.
799 Power-assisted foot/hand- propelled tricycle Power assisted foot/hand propelled tricycle intended specifically for use by people with disabilities. 800 Powered general-purpose operation table A general-purpose, electrically- or battery- powered adjustible table intended to support a patient during many types of surgical interventions.

801 Prefabricated/Mass- produced prescription spectacles
A prefabricated ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) intended to be worn over the eyes to provide refractive corrections to eyesight conditions such as presbyopia or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted to protect the eyes from bright light and radiation. 802 Professional examination gown, non-sterile Intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a reusable device. 803 Proprioceptive nest Intended to give physical support and provide age-appropriate proprioceptive stimulation as well as comfort, sense of security, and tactile stimulation to pre-term babies. 804 Prosthetic external arm, non- powered A non-powered, mechanical device intended to be used as an external prosthesis for upper limb distal to shoulder joint by patients with upper limb loss or deficiency. 805 Prosthetic external foot (Winged Foot) A non-powered, mechanical device intended for persons with a lower-limb amputation to restore lost mobility. 806 Prosthetic external foot, pediatric A non-powered, mechanical device intended for children with a lower-limb amputation to restore lost mobility. 807 Protective garment for Incontinence A specially-designed device Intended to collect an incontinent patient's urine and excreta. It is not a diaper intended for children. 808 Psychiatric physical restraint Intended for use in psychiatric wards and other hospital environments to secure patient to chair, wheelchair, bed etc. to prevent self-harm or injuries to the health care professional handling the patient. 809 Public respirator (2 ply, 3 ply face mask) A non-sterile filtering mask intended to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from exposure to pathogenic biological airborne particulates during a public health medical emergency. 810 Pulmonary exerciser The device is a handheld device that is intended to improve expiratory/exhalation and inspiratory/inhalation muscle strength for the enhancement of breathing, coughing, swallow, voice and fitness.

811 Pupillograph Intended for recording the response of the pupil to reflected light for ophthalmic diagnostic purposes. 812 Radiation face protector Intended to protect the face and eyes of medical personnel and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and treatment. 813 Radiation protection apron Intended to protect the patient, the operator, and other personnel from radiation exposure during a medical or dental procedure. 814 Radiation protection blanket Intended to protect specific body parts of the patient, operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment. 815 Radiation protection cap Intended to protect the head of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical procedures for diagnosis and treatment. 816 Radiation protection collar Intended to protect the neck or thyroid of the patient, the operator, and other personnel from unnecessary radiation exposure in medical/dental procedures for diagnosis and treatment. 817 Radiation protection gloves Intended for complete protection of the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. 818 Radiation protection goggles Intended to protect the eyes of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with medical/dental procedures for diagnosis and treatment. 819 Radiation protection mitten Intended to protect the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. 820 Radiographic film illuminator/X-ray LED view panel/ view box Intended to be used to illuminate and view medical radiographs, including X-ray, CT, MRI, ultrasound, etc. It does not have additional functional uses. 821 Radiographic film marking system/ Radiographic film marker, noninvasive, reusable A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light. It is not a ruler.

822 Radiographic film processor, automatic It transports dental x-ray film from one solution to the next in the film developing process without any manual labour except the insertion of the film/cassette. 823 Radiographic film, non- screen Intended to record images during diagnostic radiologic procedures. 824 Radiographic grid/X-ray grid/Anti-scatter grid A device intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. 825 Radiographic head holder Intended to position the patient's head during a radiographic procedure. 826 Radiographic intensifying screen It is intended to be used to reduce the X-ray dose to the patient and to allow for shorter exposure times to reduce motion artefact on exposed film. 827 Radiographic/X-ray cassette holder (wall-mounted/ceiling mounted/floor standing) Intended to be used as a support to hold and position radiographic cassettes (not included) for a radiographic exposure for medical use. 828 Radiologic patient cradle Intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures. 829 Radiologic table Intended for medical purposes to support a patient during radiologic procedures. 830 Radiological breast positioning device, wearable The device is intended to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning.
831 Radionuclide test pattern phantom A radionuclide test pattern phantom is intended to serve as a test object for evaluating a performance characteristic of an imaging device. 832 Reciprocating walking frame Intended to be used a walking aid by people with physical disabilities or poor balance. 833 Reclining wheelchair A walking aid that reclines enabling the person to change positions from sitting to lying down. 834 Rectal dilator, reusable Intended to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function. This is a reusable device. 835 Rectal speculum, reusable to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device. 836 Rectoscope/proctoscope handle Intended to be used as a handle to hold a rectoscope or proctoscope (not included) during
an examination procedure.

837 Rectosocope/proctoscope handle end-cap Intended to be fitted to the proximal end of the handle of a rectoscope or proctoscope (not included) during an examination procedure to provide an airtight seal so that air can be
pumped through the scope to inflate the bowel. 838 Rescue blanket/ Emergency Heat loss prevention blanket
A non-powered device intended to keep a person warm and/or to prevent the further loss of body heat in emergency/rescue situations. 839 Retractor holder, reusable Intended for mounting of surgical retractors. 840 Retractor, abdominal, reusable A surgical instrument intended for separating the edges of an abdominal incision to expose or access organs or tissues to permit examination or intervention. This is a reusable device intended for transient use only. 841 Retractor, cardiovascular, reusable A manual surgical instrument intended for use in cardiothoracic surgery to support stabilisation and positioning of various anatomical structures. It is not intended for use in CABG procedure and/or retraction of incisions in the heart. This is a reusable device intended for transient use. 842 Retractor, ear/nose/throat, reusable A manual surgical instrument intended for separating or drawing aside the margins of a surgical incision made during ear/nose/throat (ENT) surgery or various structures of these anatomical locations. This is a reusable device for transient use only. 843 Retractor, laminectomy, reusable A reusable, manual surgical instrument intended to separate the margins of an incision to permit excision of the lamina of the vertebral posteria arch. This is a reusable device intended for transient use only. 844 Retractor, orthopaedic, reusable intended to be used to separate and/or draw back, or separate, tissues to permit access to skeletal structures for examination or intervention. This is a reusable device intended for transient use.
845 Retractor, plastic surgery, reusable A reusable manual surgical instrument intended for use in plastic surgery for separating tissue or other anatomical parts to expose or access organs or tissues. This is a reusable device intended for transient use only. 846 Reusable dermatome blade A blade that is a component of a dermatome intended to harvest the skin graft. This device is reusable after sterilization.

847 Reusable Surgical file A manually operated, hand-held surgical instrument intended to smooth out, grind off, or sever tissues. This is a reusable device intended for transient use. 848 Reverse-image mirror, dental A device intended to be placed at the back of the teeth while taking image for dental examination purposes.
849 Rib belt Intended for providing support and compression to the ribcage and relief from rib pain and discomfort, especially after injuries or surgeries, supporting breathing and coughing during recovery, and preventing rib injuries in certain sports or physically demanding professions. 850 Rib rongeur, reusable to cut and shorten rib bones, and round the rib stumps, during a surgical intervention. This is a reusable device. 851 Rigid non-bladed video intubation laryngoscope, reusable A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. This is a reusable device intended to be sterilized prior to use.
852 Rollator /Wheeled-walker mobility aid Intended as a walking aid for balance and stability in individuals with limited mobility.
853 Rubber dam frame A flexible border intended to hold a rubber dam in a stretched state to improve access to the field of operation. This is a reusable device. 854 Rubber dam punch A hand-held dental instrument intended to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. 855 Rubber dam, Natural rubber latex A dental device made of Hevea natural rubber latex (NRL) that is punched with holes and placed over the teeth during dental procedures for uses such as 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection.
856 Rubber dam, non-latex A dental device made of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedure for uses such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection.

857 Sacroiliac joint transarticular fixation/ Arthrodesis kit, reusable A collection of hand-held, manual, non- measuring surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool. The implant(s) is not included. This is a reusable device intended for transient use. 858 Scalp clip applier, reusable A hand-held, manually-operated, surgical instrument intended for the application (the attachment) of nonimplantable, single-use scalp clips (not included) to the margins of a scalp wound/incision during a surgical intervention on the cranium/scalp. This is a reusable device. 859 Scalp clip forceps, reusable A hand-held, manually-operated, surgical instrument intended to manually apply and remove haemostatic scalp clips (not included) from the scalp during or after a surgical intervention on the cranium/scalp. This is a reusable device. 860 Scalpel blade remover, non- sterile Intended to assist the removal of used/blunt blades from a scalpel handle during a surgical procedure. 861 Scalpel, reusable to manually cut or dissect tissue. This is a reusable device intended for transient use. 862 Scissors, dental, collar/crown, reusable A hand-held dental instrument intended to cut dental metal bands. This is a reusable device. 863 Scissors, dental, surgical tissue/ Dental surgical scissors, reusable A hand-held dental instrument intended to cut oral tissue during a dental surgical procedure. This is a reusable device for transient use. 864 Scissors, ear/ Alligator scissors, reusable A long, thin, hand-held manual surgical instrument intended to cut tissue during ear surgery; it is not intended for insertion through an endoscope. This is a reusable device for transient use. 865 Scissors, general-purpose, reusable to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). This is a reusable device. Not intended for direct contact with central circulatory/central nervous system.

866 Scissors, gynaecological, reusable to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. This is a reusable device for transient use. 867 Scissors, orthopaedic, reusable A manual, hand-held surgical instrument intended to cut bone or cartilage tissue during orthopaedic surgery. This is a reusable device for transient use. 868 Scissors, plastic surgery, reusable A hand-held, manual instrument intended to cut tissue during plastic surgery. This is a reusable 869 Scissors, rectal, reusable A hand-held, manual instrument intended to cut tissue during rectal surgery. This is a reusable 870 Scissors, suture, reusable A hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It is not a dedicated ophthalmic device. 871 Scissors, thoracic, reusable intended to cut tissue located in the thoracic cavity. This is a reusable device intended to be sterilized prior to use. 872 Scissors, tonsil, reusable A hand-held surgical instrument intended to cut tonsil tissue during ear/nose/throat (ENT) surgery. This is a reusable device intended for transient use. 873 Scissors, umbilical cord, reusable specifically to cut the umbilical cord after birth. This is a transient-use, reusable device. 874 Scissors, wire cutting, ENT to cut wire used to construct ossicular replacements. This is a reusable device. 875 Sclerotome, reusable A hand-held manual ophthalmic surgical instrument intended to be used to incise the sclera during a sclerotomy. This is a transient- use reusable device. 876 Scoop stretcher Intended to transfer a trauma patient and reduce the chance of undesirable movement of injured areas. 877 Screw extractor, reusable A hand-held manual surgical tool intended to remove damaged implanted screws. This is a non-measuring, reusable device intended for transient use.

878 Screw-extraction orthopedic reamer, reusable A surgical tool intended for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. This is a reusable device. This does not have a measuring function. 879 Self-retaining ear speculum, reusable A hand-held manual instrument intended for expanding or stretching the tissue around the ear orifice when inserted and opened, typically during ear/nose/throat (ENT) intervention. It does not have any additional features/intended purposes and cannot connect to high-risk active devices. 880 Self-retaining surgical retractor, reusable A hand-operated, self-retaining, surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery. This is a reusable device intended for transient use only. 881 Shaped ankle wedge prosthesis, adult Intended to be used as external artificial joint that is designed to replace the ankle joint in adults. 882 Shaped ankle wedge prosthesis, pediatric Intended to be used as external artificial joint that is designed to replace the ankle joint in children 883 Sharp surgical instrument counting tray/pad A device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. 884 Sharps collection container A hard-walled container intended for the safe deposit and collection of biologically or chemically contaminated used sharps (e.g., needles, lancets, scalpel blades, cannula) that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. It is intended to be incinerated and disposed when filled. 885 Shield, resuscitation To minimise tissue contact and exchange of fluids between parties during mouth to mouth resuscitation. 886 Shoulder immobilizer Intended to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound.

887 Shoulder wheel
A non-powered device intended for use to perform resistance exercises to improve range of motion and relieve pain in patients (intended for hospital use). 888 Silicone prosthetic ear Intended to adhere to the skin as an artificial external ear using safe, biocompatible glue for patients born with microtia and other birth differences such as Treacher Collins or Goldenhar syndrome; as well as those who have suffered traumatic injury or undergone cancer resection surgery. 889 Silicone prosthetic nose Intended to restore normal contour and improve function for patients who have experienced partial or total loss of their nose to traumatic injury, disease or due to surgical removal of the nose (rhinectomy). 890 Single-chamber venous compression system garment These garments are intended for use with a single-chamber venous compression system (not included) in preventing deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency. 891 Sitz bath chair Intended to support a person in sitting position for external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. 892 Sitz bath kit A collection of non-sterile devices and supplies intended to be used for the administration of Sitz bath external hydrotherapy to maintain patient hygiene and to alleviate pain and discomfort caused by haemorrhoids, uterine cramps, labour, and/or other diseases of the pelvic, abdominal and perineal area. It typically consists of a basin (e.g., a rigid plastic basin), an irrigation set with a bag, tubing, clamps and towels.
893 Sitz bath, non-powered A non-powered device Intended to be filled with heated water for use in external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. 894 Skin abrasion file/ Podiatric bur, reusable Intended to be used by a podiatrist for debridement of thickened nails and callus. 895 Skin adhesive protective material Intended to protect healthy skin from friction during removal of tapes and films. It provides a thin protective layer on the skin and helps tape and film adhesion.

896 Skin graft mesher, reusable A manually operated device intended to perforate and stretch the donor skin graft with a pattern of lacerations before the skin is grafted to the patient. This is a reusable device. 897 Skin marker guide A non-sterile device intended to be used as a guide to create markings on the skin surface with a drawing skin marker, typically to outline a surgical incision site or for dermatology applications.
898 Skin marking transfer paper A non-sterile, non-invasive device intended to transfer a grid of ink dots onto the skin surface to assist a clinical procedure. This is a single-use device. 899 Skin pressure protectors Intended to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores) 900 Skin staple remover, reusable to be used to remove skin staples from a wound or incision that no longer requires stapling to stay closed. This is a reusable device. 901 Skin traction kit It is intended to provide traction for fractured femur. 902 Skin-cover sealant/Synthetic polymer liquid barrier cream This is a non-cytotoxic liquid skin barrier film for intact skin only intended to form a transparent flexible film to prevent skin irritation caused by moisture e.g. urine, friction from bedding or by adhesive products, etc. Intended for intact skin. This does not contain pharmaceuticals and not intended for use on wounds or for any therapeutic purposes. 903 Skull plate anvil, reusable A non-powered surgical instrument intended to form alterable skull plates in the proper shape to fit the curvature of a patient's skull. This is a reusable device. 904 Slit Lamp Intended to be used as a specialized magnifying microscope to examine the structures of the eye (including the cornea, iris, vitreous, and retina), without having a measuring function. 905 Snoring sensor Intended for use in the detection of snoring, muscle movement, respiratory effort and/or airflow. It does not have a measuring function. 906 Soft dental reliner Intended to be used as a tissue conditioner and a reliner for short term use for removable dentures. It may be intended for professional and/or home use. 907 Soft rehabilitation glove
Intended for rehabilitation training of patients with finger joint dysfunction.

908 Soft-tissue surgical forceps, alligator/ Alligator forceps/Crocodile forceps, reusable to facilitate grasping and manipulation of soft- tissues/anatomical structures; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. This is a reusable device intended to be sterilized prior to use. 909 Soft-tissue surgical forceps, scissors-like, reusable A hand-held, manual, open-surgery instrument intended to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. This is a reusable device intended to be sterilized prior to use. 910 Soft-tissue surgical forceps, tweezers-like, reusable A hand-held, manual, open-surgery instrument intended to facilitate grasping and manipulation of soft-tissues. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use. 911 Solid-ankle-cushion-heel (SACH) foot Intended for persons with a lower-limb amputation to restore lost mobility 912 Spine orthosis An externally-applied wearable appliance intended to support and correct deformities of the spine.This is a single-patient reusable device. 913 Spring-loaded dental mallet, reusable A hand-operated spring-loaded device with variable power intended to be used to condense gold (Au) foil or seating dental inlays. This is a reusable device. 914 Stair chair Intended to support and transport a person with disability in a seated position up or down a set of stairs. 915 Standing wheelchair Intended as a walking aid that allows users with limited mobility to raise themselves in upright position using upper limbs. Not intended for gait training or measuring functions. 916 Stationary patient lift, electric An electrically-powered, fixed assembly of devices intended to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist. 917 Stationary patient lift, manual A non-powered, fixed assembly of devices intended to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist.

918 Sterilization container A device intended to contain medical instruments during sterilization. This is a reusable device. 919 Sterilization/disinfection containers Intended to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector (not included) and/or sterilizer (not included) during the washing/disinfection and/or sterilization cycle(s). 920 Sterilizer/disinfector rack A non-sterile rack intended to hold medical devices in a steriliser or chemical washer/disinfector (not included) during the sterilisation or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their storage. This is a reusable device. 921 Sternal binder Intended to stabilize and support the sternum after sternotomies 922 Strabismus ophthalmic hook/ Eye muscle hook, reusable to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is not designed for intraocular use. 923 Suction system filter, non- sterile A filter intended to be used with a suction system to separate tissue from the fluid waste collected from a medical procedure. Not intended for collection/separation of allografts. 924 Suction/irrigation system canister/bottle holder A device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle (not included) that is used within a suction and/or irrigation system. This is a reusable device. 925 Surgeon Chair Intended to be occupied by a surgeon in a seated position during surgical procedures to provide the surgeon with support for the back and arms. May be electric and adjustable. 926 Surgical apparel, non-sterile Intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate. 927 Surgical binoculars, reusable Intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention.

928 Surgical brassiere It is intended to be used as a compression device after breast surgery to prevent the formation of oedema and to support venous return and lymphatic drainage. It does not contain pharmaceutical agents. 929 Surgical bulldog clamp, reusable A manual surgical instrument intended to grasp, join, compress or support an organ, vessel or soft-tissue. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a reusable 930 Surgical camera and accessories Intended to be used to record operative procedures, without having any measuring function. 931 Surgical camera holder Intended to hold and position a camera, or camera system and/or other devices during surgical procedures. 932 Surgical cap, non-sterile Intended to protect face of patient and the operating room personnel from the transfer of micro-organisms, body fluids & particulate material. 933 Surgical clip rack, reusable A device typically intended to be used as a container to hold and protect implantable clips (not included) during the sterilization process. 934 Surgical Dilator, reusable for enlarging cavities or openings during surgical procedures. This is not intended to be be used on central-circulatory or/and central nervous system. This is a reusable device, intended for transient use. 935 Surgical dissector, reusable to separate a soft tissue or body structure from another. This is a reusable device intended for transient use. 936 Surgical drill guide, reusable A manual surgical device intended to simultaneously place, angle, and guide a surgical drill on hard tissue (e.g., bone). This is a non- measuring, reusable device intended for transient use. 937 Surgical eye pressure shield A non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare professionals, equipment, or due to the orientation of the patient).

938 Surgical gown, non-sterile/ Operating room gown A non-sterile garment intended to be worn by health care staff over a scrub suit for surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a reusable garment. 939 Surgical guillotine, reusable Intended for severing tissue as a means to prevent infection/drainage of infected site. This is a reusable device. 940 Surgical hair clippers A hand-held electrically-powered device intended for removing long hair from the head or body of a patient prior to surgery/treatment. The device is typically operated by a healthcare professional. 941 Surgical hair clippers blade A non-sterile cutting component of powered surgical hair clippers intended for removal of long hair from the head or body of a patient prior to surgery/treatment. This is a single-use device. 942 Surgical hair clippers suction system An assembly of devices intended to be used in conjunction with hair clippers (not included) to remove cut hair through suction, typically as part of hair removal prior to surgery.
943 Surgical hair clippers suction system tubing set A non-sterile length of flexible tubing and associated items intended to be used with surgical hair clippers as a component of a surgical hair clippers suction system, during removal/collection of cut hair through suction, typically as part of hair removal prior to surgery.
944 Surgical helmet system, non- sterile A non-sterile system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It may have a power-supply and battery pack to drive internal ventilation. It does not contain sterile, disposable items.
945 Surgical helmet, non-sterile A non-powered device intended to be worn by operating room personnel (the surgeon or assisting doctors/nurses) during a surgical procedure to protect them from the transfer of microorganisms, body fluids, and particulate material which may inadvertently come into contact or splash into their face. This is a reusable device. 946 Surgical implant handling forceps to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. This is a reusable device intended to be sterilized prior to use.

947 Surgical instrument assist arm system The device is intended to assist in maintaining spatial positioning of instruments during surgical procedures. 948 Surgical instrument containment holder, single- use, non-sterile A non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. 949 Surgical instrument handle, non-torque-limiting to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw, reamer, dental implant, mucotome, or soft-tissue coring punch; it does not include a torque-limiting function. This is a reusable device. 950 Surgical instrument holder, reusable A device intended to be used in the operating room (OR) by staff to safely contain a delicate or sharp hand-held, manual, surgical instrument(s). 951 Surgical instrument interim- placement holder, reusable A device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). 952 Surgical instrument rack Intended for the safe storage and counting of used sharps during and prior to the the end of a surgical procedure. The used sharps may be held in place by foam, magnet or other mechanisms and the device can be closed securely for safe sharps disposal. 953 Surgical knee cover Reusable surgical cover intended to be used as a protective cover to protect the patella during knee surgery. 954 Surgical lamp Intended to provide visible illumination of the surgical field or the patient. 955 Surgical lamp (ophthalmic) Intended to serve as a cold light source for illumination of the intraocular posterior segment in optical surgery in case of vitrectomies. 956 Surgical lens (camera accessory) A device intended to be used with a camera, or a camera system being used during medical procedures.

957 Surgical light/illumination system/OT lights Intended to providing optimal light and colour rendering to aid surgery. This does not have a measuring function. 958 Surgical mallet head, reusable A device intended to replace the head of some types of surgical mallets and hammers. This is a reusable device. 959 Surgical mallet/Surgical hammer, reusable to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It may also be used for autopsy. This is a reusable device. 960 Surgical material compression device, reusable A reusable manual instrument intended to flatten material, such as tissue, for use in a surgical procedure (e.g., tympanoplasty) after it has been flattened. 961 Surgical microscope and accessories Intended for use during surgery to provide a magnified view of the surgical field, without having any measuring function.
962 Surgical probe, reusable intended to explore sinuses, fistulae, and other cavities and wounds. This device is not intended to be connected to active device and does not have additional functional uses. This is a reusable device. 963 Surgical Punch/Bone Punch, reusable to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. This is a reusable device intended for transient use. 964 Surgical Retractor system blade, reusable A component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system intended to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. This is a reusable device. It is intended for transient use. 965 Surgical Retractor system, self-retaining An assembly of surgical instruments/devices intended to be used to create a self-locking, self- retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; it is not intended for neurosurgery/cardiac surgery, or ophthalmic surgery. This is a reusable device intended for transient use.

966 Surgical screwdriver, reusable A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw,etc.) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). This is a non- measuring, reusable device intended for transient use. It is not intended to be connected to an active device. 967 Surgical sleeve cover, non- sterile It is a forearm covering intended to be worn over a scrub suit by healthcare staff during procedures to maintain hygiene and prevent cross- contamination of microorganisms, body fluids, and particulate materials between the patient and staff.
968 Surgical torque wrench adaptor, reusable This is a hand-held component of a surgical wrench that is intended to connect the main body of the wrench to a variety of distal end pieces (bits) and assist with the use of a torque wench in the mouth during a dental procedure. This does not have a measuring function. 969 Surgical traction tensioner connector A connecting/extension device intended to be fastened between a surgical traction tensioner/rod/cord and a patient-contact traction device (e.g., orthopaedic bone wire, foot boot, hand wrap/trap) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis). It is intended to be used during orthopedic surgery. This is a reusable device.
970 Surgical trays Intended to provide a suitable platform for general containment of many medical/surgical instruments and related items during a clinical procedure.
971 Surgical video camera A video camera intended to generate video images of surgical procedures, which are fed to a monitor screen for local or external viewing. This does not have a measuring function.

972 Surgical/emergency suction handle A non-sterile, noninvasive, non-powered, hand- held device intended to be connected to, and facilitate manipulation of, an appropriate cannula/tip (not included) for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction; it is not intended for irrigation. It does not incorporate switch, valves, or buttons. 973 Suture Needle, reusable A non-sterile instrument intended to be used to insert and pull suture material (not included) through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. This is a reusable device intended to be sterilized prior to use. 974 Suturing Needle holder, reusable to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. This is a reusable device. 975 Suturing Unit, non-powered A non-powered, hand-held device intended to pass sutures (not included) or a needle/suture assembly (not included) through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. This is a reusable device. 976 Swivel-walker Intended to encompass and provide support for the body of a patient who is unable to stand unassisted, to help them move (walk) by rocking sideways (shifting their weight from side-to-side with a shoulder movement). 977 Synoptophor Intended for the evaluation and training of a patient's binocular function. 978 Tachistoscope Intended to flash words or images at different speeds, for the purposes of ophthalmic diagnostic testing. 979 Tearable adhesive plaster It is intended to secure dressings and for strapping on intact skin. 980 Tearable adhesive tape It is intended to secure dressings and for strapping on intact skin. 981 Teething device, fluid-filled A device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. Intended for hospital use. 982 Teething device, non- fluid- filled Intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. Intended for hospital use. 983 Tenotome, reusable intended to cut a tendon. This is a reusable

984 Tester, colour discrimination Devices intended for colour vision testing. This does not have a measuring function. 985 Testicular temperature regulation underpants A garment that is intended to be body worn around the pelvic region to keep the testicles cool for increased spermatogenesis, as part of an fertility treatment, through ventilation features (e.g., breathable mesh) that prevent excessive insulation of the testes. This is not an active device. 986 Therapeutic medical binder, general purpose Intended for medical purposes and that can be secured by ties to support the underlying part of the body or hold a dressing in place like abdominal, breast and perineal binder. 987 Therapeutic scrotal support Intended for medical purposes to support the scrotum (the sac that contains the testicles). 988 Thermoplastic mask for immobilization Intended to immobilize the patient to deliver the correct radiation dose. 989 Thick /Thin Guide Pin, reusable A non-sterile instrument intended to be used to facilitate precise placement of a cannulated screw during orthopaedic surgery. This is a reusable, non-measuring device intended for transient use. 990 Thumb spica splint Intended to minimize movement and provide support and comfort by stabilizing an injury of the thumb 991 Toe separator Intended to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. 992 Tongue depressor Intended to move the tongue to facilitate examination of surrounding organs and tissue. 993 Tongue depressor, surgical A hand-held surgical instrument intended to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. The device is generally used in oral surgery (e.g., during tonsillectomy). This is a reusable device. 994 Tongue-retaining sleep- disordered breathing orthosis A removable intraoral device intended to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by retention of the tongue, frequently keeping the tongue in a forward position during sleep. 995 Tonsil knife, reusable intended to be used in surgery of the anatomical features of the tonsils and their remoal. This is a reusable device. 996 Torque Wrench, reusable A manually operated surgical instrument intended for gripping, turning or twisting ,loosening, etc. of an object, e.g., a nut, wire, etc. This is a non- measuring, reusable device.

997 Tracheal bistoury, reusable intended for opening abscesses or slitting up sinuses and/or fistulas in the trachea. This is a reusable device. 998 Tracheal surgery dilator, reusable Intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. This is a reusable device. 999 Tracheostoma protector Intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma. 1000 Tracheostoma shower shield A non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering. 1001 Tracheostomy tube holder Intended to secure a patient’s tracheostomy tube for use on pediatric (neonates, infants and children) patients. 1002 Tracheostomy tube lubricant Intended to be applied by healthcare staff or a patient to the outer surface of a tracheostomy tube inner cannula to facilitate its easy sliding into the outer cannula. 1003 Tracheostomy tube neck holder, single-use A non-sterile device intended to secure a tracheostomy tube by fastening around the neck of the patient.
1004 Tracheotome, reusable A surgical instrument intended to cut an opening into the trachea (windpipe) through the anterior surface of the neck to create an artificial airway (tracheotomy). This is a reusable device intended to be sterilized prior to use. 1005 Truncal orthosis Intended to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. 1006 Tuning fork, ENT A non-powered, non-invasive device intended to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. 1007 Ulnar/brachial nerve protector A non-powered, non-invasive device intended to provide cushioning, support and protection to elbow and arms during prolonged surgeries.
1008 Ultrasonic coupling gel, non- sterile A coupling medium intended for use during ultrasound examinations for ultrasound transmissions. 1009 Ultrasonic safety goggle
Intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure.

1010 Ultrasonic scanner calibrator/ Ultrasonic scanner calibration test block It is a block of material with known properties intended to be used to calibrate ultrasonic scanning devices. 1011 Ultrasound imaging phantom, test object Intended to provide a standard of reference for routine and periodic verification of ultrasound doppler imaging equipment used for the identification of disease and pathologies. 1012 Ultrasound imaging system table, non-powered A non-powered patient table intended to support and position a patient specifically for ultrasound imaging procedures. 1013 Ultrasound imaging system table, powered An electrically-powered patient table intended to support and position a patient specifically for ultrasound imaging procedures. 1014 Ultrasound imaging transducer positioning unit An accessory to a diagnostic ultrasound imaging unit intended to position an ultrasound system imaging transducer (not included) that is inserted into the body through an endoscope.
1015 Umbilical cord clamp, reusable A non-sterile device intended for clamping the umbilical cord after birth. This is a reusable device. 1016 Umbilical ligator, reusable Intended for umbilical cord ligation during surgical procedures. This is a reusable device intended for transient use. 1017 Urinary dilator, reusable Intended to dilate the urinary duct. This is a reusable device. This is not intended for long- term use and not connected to an active device. 1018 Urinary-incontinence vaginal insert, reusable A non-sterile device intended to be inserted into the vagina (short-term) in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). 1019 Urological operating table top A component of a modular operating table intended for use as a detachable table top to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. 1020 Urological operating table, electrohydraulic A mobile, mains electricity (AC-powered) hydraulic-mechanism table intended to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. This does not have a measuring function.

1021 Urological operating table, electromechanical A mobile, electrically-powered motorized table intended to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. This does not have a measuring function. 1022 Urological operating table, hydraulic/Transurethral resection table A mobile table powered by manually-operated hydraulic mechanisms intended to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract. This does not have a measuring function. 1023 Uterine packer, reusable Intended for introducing dressings into the uterus or vagina. This is a reusable device. 1024 Vacuum cushion (Patient- positioning device) Intended for positioning and re-positioning patients’ head and neck, thorax, hip and full body during radiation therapy and other diseases treatment. 1025 Vacuum splint Intended to immobilize and protect injured limbs so that the patient can be transported safely and easily in emergency conditions. 1026 Vaginal applicator, non- sterile, single use A non-sterile, single use device intended to apply medication to the vagina. 1027 Vaginal applicator, reusable
Intended to apply medication to the vagina. This 1028 Vaginal exerciser/Pelvic floor muscle exerciser, female Intended to provide Kegel exercises to strengthen and tone the pelvic floor muscle, which in turn improves conditions such as female incontinence, sexual dysfunction, prolapse, etc.
1029 Vaginal illuminator A device intended to illuminate the vagina during a gynaecological examination or procedure. 1030 Vaginal speculum, reusable A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It does not have any additional features/intended purposes and cannot connect to high-risk active devices. This is a reusable device. 1031 Valsalva manoeuvre mouthpiece Intended to be inserted into a patient's mouth to facilitate performance of the Valsalva manoeuvre.

1032 Vascular compression bandage, reusable A stretchable piece of fabric material intended to provide pressure for haemostasis to a punctured site on a patient having undergone femoral artery catheterization or venipuncture. It may also be used on radial and brachial arteries. It is not a surgical dressing. This is a reusable device after appropriate sterilizing. 1033 Vascular compression system, reusable A noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure. It may in addition be used on brachial and radial arteries or after venipuncture. This is a non-measuring, reusable device. 1034 Vascular scissors/ micro- scissors, reusable intended to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery; it is not intended for endoscopic use. This is a transient-use, reusable device intended to be sterilized prior to use. Not intended for direct contact with the central circulatory/central nervous system. 1035 Vein stripper, reusable A hand-held surgical instrument intended to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. 1036 Vice grip, reusable Intended to hold pliers during surgical procedures. This is a reusable device. 1037 Video indirect ophthalmoscope Intended as an illumination system to direct appropriately focused light into the eye in order to obtain an intermediate image of the fundus (retina) and record the images and videos of the patient. 1038 Video intubation laryngoscope handle/monitor Intended to enable the positioning of the blade into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. 1039 Video laryngoscope adaptor Intended to serve as a connection between the laryngoscope and the display/monitoring device during intubation.

1040 Vision testing/training flipper A device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders.
1041 Vision training software A patient-interactive software package intended to use visual images (e.g., Gabor patch) to help improve vision based on noninvasive perceptual learning therapy (neuro-vision therapy), typically in patients with amblyopia, or who use corrective eyewear, or following ophthalmic surgery. This does not have a measuring function. 1042 Visitor hygiene coverall A garment intended to be worn over existing clothing by a visitor, or staff, in a healthcare facility when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. This is a single-use device. 1043 Visual chart Intended for use in testing visual acuity. 1044 Visual light box Intended for use in testing visual acuity. 1045 Visual projector Intended to project an image on a screen to test visual acuity . 1046 Visual field plotter Device intended for visual field examination 1047 Vitrectomy lenses Intended to facilitate the visualization of the retina during Vitrectomy surgery. 1048 Waiting area chair Intended for use in hospitals/health care settings for supporting patients and their next of kin while waiting for a medical examination/treatment. 1049 Wash basin stand Intended to be used in a hospital environment to support a wash basin used for the thorough cleaning/scrubbing of the hands, fingernails, and arms of health care personnel before surgery or other procedures that require a high level of hygiene. 1050 Washers for body waste receptacles Intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan. 1051 Weight activated knee joint external prosthesis Intended as an artificial external knee with a braking mechanism that prevents the knee from bending as long as the user has weight on the prosthesis. 1052 Weight-bearing protector for flat panel x-ray detector/film cassette The device is intended for use as a protector for a digital X-ray flat panel detector. 1053 Wheelchair
Intended to be used by physically disabled individuals and old age patients with limited mobility.

1054 Wheelchair accessory, power assisted conversion kit A device intended to be specifically used together with and to enhance the function of a wheelchair. It will provide the occupant/assistant with a powered driving assistance. 1055 Wire tensioner, reusable Intended to be used during orthopaedic surgery to apply an appropriate tension to a wire that is being implanted. This is a non-measuring, reusable device. 1056 Woven gauze pad, non- sterile A non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) intended to absorb fluids from superficial wounds or abrasions. This may also be used to apply topical medication. 1057 Woven gauze roll, non-sterile A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically intended for a variety of applications (non- dedicated) such as a primary wound dressing (superficial wounds), dressing retention, injury padding and compression. 1058 Woven gauze sheet, non- sterile A non-sterile device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose) intended for a variety of applications (non-dedicated) such as a primary superficial wound dressing, dressing retention, and injury padding and compression. 1059 Wrist immobilizer Intended to temporarily render the wrist immovable as therapy for non- displaced fractures, strains, sprains, and muscle injuries of the wrist. 1060 Wrist splint Intended to temporarily render the wrist immovable as therapy for non-displaced fractures sprains & muscle injuries of the wrist. 1061 Wrist/hand/finger flexion orthosis, manual An externally applied orthopedic appliance intended to assist in the flexion of the wrist, hand, and fingers 1062 Wrist/hand/finger stable- position orthosis An externally applied orthopaedic appliance or apparatus intended to maintain both the transverse and longitudinal arches of the hand, and to hold the thumb in a functional position. 1063 Wrist/hand/metacarpophalan geal joint extension orthosis Intended to assist in the extension of the wrist, hand, and metacarpophalangeal joints (MP joints or knuckles). 1064 X- ray marker for strut Intended to be used in Six axis correction apparatus with software. 1065 X-ray film cover
A small envelope cover intended to hold and protect x-ray films that goes into a patient's mouth momentarily when taking an x-ray and then processed.

1066 X-ray film magnifying glass A convex lens intended for magnifying the details of a viewed radiograph (x-ray) and shade against strong interfering light.
1067 X-ray film processing chemical, automatic A chemical, e.g., a fixer or developer, intended for automatic processing of x-ray film or other radiographic films used in, e.g., computed tomography (CT), magnetic resonance (MR), ultrasound or nuclear medicine. 1068 X-ray film processing chemical, manual A chemical, e.g., a fixer or developer, intended for use in the manual processing of x-ray film or other kinds of radiographic film used in medical applications, e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound and nuclear medicine applications. 1069 X-Ray hanger Intended to position and hold the radiograph during X ray film development, eliminate streaking and maintain alignment.