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145 List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017 2023-Sep-15 1635 KB

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No. 29/Misc/03/2019-DC (211)-Part 1 Government of India Directorate General of Health Services Ministry of Health & Family Welfare Central Drugs Standard Control Organisation (Medical Devices and Diagnostics Division)

Date: 1 ) SEP 2023

Subject: List of the registered Medical Device Testing Laboratory (MDTL) under MDR, 2017- regarding test This office had registered Medical Device Testing Laboratories (MDTL) to carry out or evaluation of a medical device on behalf of the manufacturer (Form MD-40) under Medical Devices Rules, 2017. The updated list of Medical Devices Testing Laboratories registered with CDSCO under the provisions of Medical Devices Rules, 2017 to carry out test or evaluation of a medical device on behalf of manufacturer as on date 12.09.2023 is given as under:

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----- Start of picture text ----- NAME & ADDRESS OF MEDICAL DEVICE! REGISTRATION TESTING NO. SCOPE OF TESTING LABORATORY 1 M/s SIPRA LABS TL/MD/2019/000001 | 1. Copper -T LIMITED 2. Condoms Address: 7-2- 3. Sterile Hypodermic Needles 1813/5/A, Adj. To Post 4. Tubal Rings | Office,Estate, IndustrialSanathnagar, 6.5. HypodermicBlood Bags Syringes Telangana, Hyderabad- 500018 2 M/s Star Imaging & TL/MD/2019/000002| 1. Bilirubin (Total and Direct) Test Path Lab Pvt. Ltd. Reagents / Kits Address: 4B/4, Tilak 2. Creatinine test reagent / kit NagarDelhi , West Delhi, 3. Aspartate Amino Transferase (AST/ (India) - 110018 SGOT) test 4. Alanine Amino Transferase (ALT/SGPT) test 5. Uric Acid Test reagents/ kits 6. Total Protein test reagents / kits 7. Activated partial thromboplastin time (APTT) test 8. PT (Prothrombin Time) Test reagents / Kits ----- End of picture text -----

|~|~|3||Mls|MlsAlcatec<br>Research||TL/MD/2019/000003||1. Sterilized Surgical Ligatures<br>2. Sterilized Disposable Device|
|---|---|---|---|---|---|---|
||||Laboratories India|||3.Sterilized Surgical Sutures|
||||Pvt. Ltd.||||
||||Address:<br>1652|MIE|||
||||Part<br>B,<br>Bahadurgarh,||||
||||Haryana — 124507||||
||4||M/s Sree Chitra||TLIMD/2019/000004|1.Cardio|1.Cardio Vascular Devices (Biological|
||||Tirunal Institute For|||Evaluation as per ISO 10993)|
||||Medical Sciences|&||2.Neuroprosthesis (Biological|
||||Technology<br>Address: Medical|||Evaluation as per ISO 10993)<br>3.Orthopedic Implants (Biological|
||||College,<br>Thiruvananthapuram,<br>Kerala -695011|||Evaluation as per ISO 10993)<br>4.All medical devices and Materials<br>(Biological Evaluation as per ISO|
|||||||10993)|
||.<br>5|||M/s,GLR<br>Laboratories Private<br>Limited||TL/MD/2019/000005|5**.**DentalImplants(BiologicalEvaluation<br>asperISO10993)<br>1<br>Cardiovascular devices (Biological<br>evaluation as per ISO 10993)<br>2. Orthopaedic devices (Biological|
||||Address: GOKULAM<br>STREET, Mathur,<br>MATHUR, Chennai,<br>Tamil Nadu - 600068|||evaluation as perISO 10993)<br>3. Oculardevices (Biological evaluation<br>as per ISO 10993)<br>4.<br>Surgical devices and sutures<br>(Biological evaluation as per ISO|
|||||||10993)|
|||||||5.<br>Respiratory devices (Biological|
|||||||evaluation as per ISO 10993)|
||||||||'6. Gastrointestinal devices(Biologicai<br>evaluation as per ISO 10993)|
|||||||7.<br>Urological devices (Biological!|
|||||||evaluation as per ISO 10993)|
|||||||8.<br>Haematological devices and IV sets|
|||||||(Biological evaluation as perISO|
|||||||10993)|
|||||||9.<br>Dental devices (Biological evaluation|
|||||||as per ISO 10993)|
|||||||10.Personal care products and family|
|||||||planning (Biological evaluation as|
|||||||per ISO 10993)|
|||||||11.Neurological devices (Biological|
|||||||evaluation as per ISO 10993)|
|||||||42. All medical devices and Materials|
|||||||(Biological evaluation as per ISO|
|||||||10993)|
||6||M/s, PALAMUR<br>BIOSCIENCES||TL/MD/2019/000006||1. Catheters (Biological Toxicity)<br>2. Disposable Hypodermic needles|
||iz||PRIVATELIMITED|||(BiologicalToxicity)|

|i|~||Address: 401 Aikya,<br>4th Floor, H.No-10-3-<br>32/9/23, Opp.Faust||3. Surgical dressings (Biological<br>Toxicity)<br>4. Orthopaedic Implants (Biological|
|---|---|---|---|---|---|
||||High School,East<br>Marredpally,<br>Secunderabad,<br>Hyderabad,<br>Telangana - 500026||Toxicity)<br>5. Blood Bags (Biological Toxicity)<br>6. Drug eluting stent (Biological<br>Toxicity)<br>7.<br>Intra OcularLenses (Biological<br>Toxicity)|
||||||8. Sutures (Biological Toxicity)|
||||||9. Condoms (Biological Toxicity)|
||||||10.HeartValves (Biological Toxicity)|
||||||11.Disposable perfusion sets (Biological|
||||||Toxicity)|
||||||12.Cardiac stent (Biological Toxicity)|
||||||13.Copper-T (Biological Toxicity)|
||||||14. Scalp Vein Set (Biological Toxicity)|
|||7|M/s, Eurofins|TL/MD/2020/000001||1. Disposable Perfusion Sets|
||||Advinus Limited||2. Cardiac Stents|
||||Address: 21 & 22,||3. Drug Eluting Stents|
||||Phase Il, Peenya<br>Industrial Area,<br>Bengaluru<br>Pincode 560 058,||4. Blood Bags<br>5. Catheters (Class D)<br>6. Catheters (Class B)<br>7. Catheters (Class C)|
||||INDIA, Bangalore,<br>Bengaluru<br>(Bangalore) Urban,<br>Karnataka - 560058||8. Heart valves<br>9.<br>Intra Ocular Lenses<br>10.1.V. Cannula<br>11.Bone Cements|
||||||42.Internal Prosthetic Replacements|
||||||13.Peritoneal dialysis sets|
||||||14.Condoms|
||||||15. Intra-uterine devices|
||||||16.Surgical dressing|
||||||17.Scalp Vein Set|
||||||18.Ligatures and sutures|
|||8|M/s, TRUSTIN<br>ANALYTICAL<br>SOLUTIONS|TL/MD/2020/000002||1. Disinfectant ( Sterility and<br>Antimicrobial activities as per ISO<br>11737-1 and 2, USP|
||||PRIVATE LIMITED||42, EP 9.0, IP 2018, BP 2018)|
||||Address: Plot no-<br>303/b, Block-B,<br>RKComplex, 1°<br>Floor, Thiruneermalai<br>road, Parvathy puram,<br>Chrompet,<br>,<br>Chennai,<br>Kanchipuram, Tamil<br>Nadu - 600044||2. Catheters (Sterility, Bioburden and<br>BETas per ISO 11737-1 and 2, USP<br>42, EP 9.0, IP<br>2018, BP 2018) -ClassA<br>3. Surgical Sutures (Physical<br>parameters, Sterility and BETas per<br>ISO 11737-2, USP<br>42, EP 9.0, IP 2018, BP 2018) -<br>Class B<br>4.SurgicalDressings(Sterility ,|

|ty<br>,|||||
|---|---|---|---|---|
|||||||
|||||||
||||||||
||||||||

||Bioburden, BETas per IS758, IS<br>1954, ISO 11737-1and 2, IP 2018,|
|---|---|
||USP 42, BP 2018 and EN9.0) -|
||Class A|
|5.|Surgical Dressings( Sterility ,<br>Bioburden, BET as per IS 758, IS|
||1954, ISO 11737-1and 2, IP 2018,|
||USP 42, BP 2018 and EN9.0) -|
||Class B|
|6.|Surgical Dressings( Sterility<br>,<br>Bioburden, BET as per IS 758, IS|
||1954, ISO 11737-1and 2, IP 2018,|
||USP 42, BP 2018 and EN9.0) -|
|7.|Class C<br> Surgical Dressings( Sterility ,|
||Bioburden, BETasperIS758, |S<br>1954, ISO 11737-1and 2, IP 2018,|
||USP 42, BP 2018 and EN9Y.Q) -|
||Class D|
|8.|Blood bagswith and without<br>anticoagulant solutions (Mechanical,|
||Sterility and BET as per ISO 3826,|
||1S 15102, ISO 11737-2, USP42, EP|
||9.0, IP 2018, BP 2018)|
|9.|Contraceptives (Condoms -|
||Male/Female Condoms) (Mechanical|
||parameters,|
||Bioburden and Pathogens as per|
||ISO 4074-2015,WHOUNAIDS2010,|
||1SO25841-2017,|
||WHOUNAIDS2012,Schedule R,<br>1S$011737-1, IP2018, USP42|
|10.Catheters|Catheters (Sterility, Bioburdenand<br>BET as per ISO 11737-1 and 2, USP|
||42, EP 9.0, IP|
||2018, BP 2018) - Class B|
|11.Catheters (Sterility, Bioburden and||
||BET as per ISO 11737-1 and 2, USP|
||42, EP 9.0, IP|
||2018, BP 2018) - Class C|
|12.Disposable Hypodermic Needles||
||(Sterility, Bioburden and BET as per|
||ISO 11737-1 and 2, USP 42, EP 9.0,|
||IP 2018, BP 2018) - Class C|
|13.Disposable Perfusion sets (Physical||
||testing, Sterility, Bioburden and BET|
||as per ISO 1135-Part 4, IS 9824-3,|
||ISO 11737-1 and 2, USP 42, EP 9.0,|
||IP 2018, BP 2018) - Class B|
|14.Disposable Perfusion sets (Physical||
||testing<br>,Sterility,BioburdenandBET|

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||||||||||
|---|---|---|---|---|---|---|---|---|
|as|per ISO|1135-Part|4,|IS|9824-3,|
|ISO|11737-1|and|2,|USP|42,|EP|9.0,|
|IP|2018,|BP|2018)|-|Class|C|
|15.Intraocular|Lenses|(Sterility,|
|Bioburden,|BET|and|Pathogen|
|identification|as|per|ISO|11737|-|
|Part|1|and|2,|USP|42,|EP|9.0,|IP|
|2018,|BP|2018)|
|16. Orthopaedic|Implants|(Sterility,|
|Bioburden|and|BET|as|per|ISO|
|11737-1|and|
|2,|USP|42,|EP|9.0,|IP|2018,|BP|
|2018)|-|Class|C|
|17. Orthopaedic|Implants|(|(Sterility,|
|Bioburden|and|BET|as|per|ISO|
|11737-1|and|2,|USP|42,|EP|9.0,|IP|
|2018,|BP|2018)|-|Class|D|
|418.Cardiac|Stents|{|Sterility test as|per|
|1$011737-2,|USP|42,|EP|9.0,|IP|
|2018,|BP2018)-|Class C|
|19.|Cardiac|Stents|(|Sterility|test|as|per|
|ISO|11737-2,|USP|42,|EP|9.0,|IP|
|2018,|BP2018)|-|Class|D|
|20.Contraceptives|(CuT)|(Mechanical|
|parameters,|Sterility,|Bioburden|as|
|per|
|WHO|UNFPA|2016,|ISO|7439,|ISO|
|11737-1and|2,|IP|2018,|USP|42,|BP|
|2018,|EP|9.0)|
|21.Disposable|Hypodermic|Syringes|
|(Sterility|and|BET|as|per|ISO|11737-|
|2,|USP|42,|EP|
|9.0,|IP 2018,|BP|2018)|- Class B|
|22.Catheters|(Sterility,|Bioburden|and|
|BET|as|per|ISO|11737-1|and|2,|USP|
|42,|EP|9.0,|IP|
|2018,|BP|2018)|-|Class|D|
|23. Disposable|Hypodermic|Needles|
|(Sterility,|Bioburden|and|BET|as|per|
|ISO|11737-1|and|2,|USP|42,|EP|9.0,|
|IP|2018,|BP|2018)|-|Class|B|
|24. Disposable|Perfusion|sets|(Physical|
|testing,|Sterility,|Bioburden|and|BET|
|as|per|ISO|1135-Part 4,|IS|9824-3,|
|ISO|11737-1|and|2,|USP|42,|EP|9.0,|
|IP|2018,|BP|2018)|-|Class A|
|25. Disposable|Perfusion|sets|(Physical|
|testing,|Sterility,|Bioburden|and|BET|
|as|per|ISO|1135-Part|4,|IS|9824-3,|
|ISO|11737-1|and|2,|USP|42,|EP|9.0,|
|IP|2018,|BP|2018)|-|Class|C|

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----- Start of picture text ----- 5 ----- End of picture text -----

Intraocular Lenses (Sterility, Bioburden, BET and Pathogen identification as per ISO 11737 - Part 1 and 2, USP 42, EP9.0, IP 2018, BP 2018)

27.\Internal Prosthetic Replacements (Sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018)

Heart Valves (Sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018)
Surgical Sutures (Physical parameters, Sterility and BET as per

| ISO 11737-2, USP 42, EP 9.0, IP | 2018, BP 2018) - Class A 30. Surgical Sutures (Physical parameters, Sterility and BET as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018) - Class C

31.Contraceptives (Tubal Ring)(Mechanical parameters and Sterility as per IS 13009-2000, ISO 11737-2, USP 42, EP 9.0, IP2018, BP 2018)

Disposable Perfusion sets (Physical testing, Sterility, Bioburden and BET as per ISO 1135-Part 4, IS 9824-3, ISO 11737-1 and 2, USP 42, EP 9.0, IP 2018, BP 2018)-

| Class B | 33. Internal Prosthetic Replacements | (Sterility test as per ISO 11737-2, USP 42, EP 9.0, IP 2018, BP 2018)

34.IV Cannulae (Sterility, Bioburden, Pathogen identification as per ISO 11737-1and 2, USP 42, EP 9.0, IP 2018 , BP 2018)

Disposable Hypodermic Syringes (Sterility and BET as per ISO 117372, USP 42, EP9.0, IP 2018, BP 2018)

9 M/s, Devansh TL/MD/2020/000003 1. Catheters — Class A Testing & Research . Catheters (Excluding BioLaboratory Pvt. Ltd. compatibility testing) - Class B Address: RZ-21A/331, . Catheters (Excluding BioMadanpuri, Gali No.compatibility testing)- Class C 10, West Sagar Pur, . Disposable Perfusion Sets Delhi, West Delhi, (Excluding Biocompatibility testing) - Delhi - 110046 Class C

_” ,

. Disposable Hypodermic Needles | (Excluding Bio-compatibility testing) - Class C
. Disposable Hypodermic Needles (Excluding Bio-compatibility testing) - Class D
. Disposable Hypodermic Syringes - Class A
. Disposable Hypodermic Syringes (Excluding Bio-compatibility testing) - Class B
. Disposable Hypodermic Syringes (Excluding Bio-compatibility testing) - Class C
1. Disposable Hypodermic Syringes (Excluding Bio-compatibility testing) - Class D
1. |.V. Cannulae - Class A 2. 1.V. Cannulae (Excluding Biocompatibility testing) - Class B
1. |.V. Cannulae (Excluding Biocompatibility testing) - Class C
1. 1.V. Cannulae (Excluding Biocompatibility testing) - Class D
1. Scalp Vein Set - Class A 6. Scalp Vein Set (Excluding Biocompatibility testing) - Class B
1. Scalp Vein Set (Excluding Biocompatibility testing) - Class C
1. Scalp Vein Set (Excluding Biocompatibility testing) - Class D
1. Surgical Dressings - Class A 0. Surgicai Dressings (Excluding Biocompatibility testing) - Class B
1. Surgical Dressings (Excluding Biocompatibility testing) - Class C
1. Surgical Dressings (Excluding Biocompatibility testing) - Class D
1. Contraceptives - Class A 4. Contraceptives (Excluding Biocompatibility testing) - Class B
1. Contraceptives (Excluding Biocompatibility testing) - Class C
1. Contraceptives (Excluding Biocompatibility testing) - Class D
1. Disinfectant - Class A 8. Catheters (Excluding Biocompatibility testing) - Class D
1. Disposable Hypodermic Needles - Class A
1. Disposable Hypodermic Needles

|.|:|=||||||(Excluding Bio-compatibilitytesting)<br>- Class B||
|---|---|---|---|---|---|---|---|---|---|
||||||||1.|Disinfectant (Excluding Bio-||
|||||||||compatibility testing) - Class B||
||||||||2. Disinfectant (Excluding Bio-|||
|||||||||compatibility testing) - Class C||
||||||||3. Disinfectant (Excluding Bio-|||
|||||||||compatibility testing) - Class D||
||||||||4. Disposable Perfusion Sets - ClassA|||
||||||||5. Disposable Perfusion Sets|||
|||||||||(Excluding Biocompatibility testing) -||
|||||||||Class B||
||||||||6. Disposable Perfusion Sets|||
|||||||||(Excluding Biocompatibility testing)||
||||10||Mis,JAGDAMBA<br>LABORATORIES<br>| Address: 119,<br>Solitaire Industrial||TL/MD/2020/000004|1. <br>.|Catheters (Testas per IS/ISO 10555)<br>-ClassA<br> Disinfectants (As per IP, BP, USP) -<br>Class B||
||||||Park, Phase-1,<br>Dahmikallan, Bagru,<br>Jaipur, Rajasthan-<br>303007||. <br>.|Disposable Hypodermic Needles<br>(Test as per IS 10654) - Class B<br> Disposable Perfusion Sets (Testas<br>per IS 12655) - ClassA||
||||||||.|Disposable Perfusion Sets (Test as||
||||||||.|per IS 12655) - Class B<br> Catheters (Test as per IS/ISO 10555)||
|||||||||- Class B||
||||||||_|LV. Cannulae (Testas per IS/ISO||
|||||||||10555) - Class B||
||||||||.|Disposable Hypodermic Syringes||
|||||||||9.|(Testasper1S10258) -ClassB<br> Scalp vein set (Test as per IS 16097)|||
||||||||_|-ClassB||
||||||||10. Surgical Dressings (Cotton and|||
|||||||||Gauze, Bandage)-Class B||
||||||||11. Surgical Dressings (Cotton and|||
|||||||||Gauze, Bandage)-Class A||
||||11||ITLLABS PVTLTD<br>B-283-284,<br>Mangolpuri Industrial<br>Area, Phase I, North<br>West Delhi,||TL/MD/2021/000001|1.<br>.<br>.|Catheters (Excluding Bio-<br>compatibility testing) ClassD<br>Surgical Dressings (Excluding<br>Biocompatibility testing) Class D<br>Disposable Hypodermic Syringes||
||||||Delhi - 110083|||Class D||
||||||||.|Disposable Hypodermic Syringes||
|||||||||(Excluding Bio-compatibilitytesting)||
|||||||||Class D||
||||||||.|Surgical Dressings Class D||
||||||||.|Disposable Hypodermic Needles||
|||||||||(Excluding Bio-compatibility testing)||
|||||||||Class C||
||||||||||||
|||||||8||||

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||||.<br>.|Contraceptives Class D<br>LV. Cannulae (Excluding Bio-|
|---|---|---|---|---|
|||||compatibility testing) Class C|
||||.|Surgical Dressings (Excluding|
|||||Biocompatibility testing) Class D|
||||10.|Scalp Vein Set (Excluding|
|||||Biocompatibility testing) Class B|
||||11.|Disposable Hypodermic Needles|
|||||Class C|
||||12.||.V. Cannulae Class C|
||||13.|I.V. Cannulae (Excluding Bio-|
|||||compatibility testing) Class C|
||||14.|Scalp Vein Set Class B|
||||15.|Contraceptives (Excluding|
|||||Biocompatibility testing) Class D|
||||16.|Catheters Class D|
||||17.|Disinfectant Class B|
||||418.|Disposable Perfusion Sets<br>(Excluding Biocompatibility|
|||||testing) Class C|
||||19.|Disinfectant (Excluding Bio-|
|||||compatibility testing) Class B|
||||0.|Disposable Perfusion Sets Class C|
||||1.|Disposable Perfusion Sets|
|||||(Excluding Biocompatibility|
|||||testing) Class C|
||||2.|Disposable Hypodermic Needles|
|||||(Excluding Bio-compatibility testing)|
|||||Class D|
||||3.|Surgical Suture Class D|
||||4.|Urine collecting bag Class B|
|||||5.|Surgical Gloves ( Sterile/Non Sterile)|
|||||Class D|
||||6.|Endotracheal (ET) tube Class B|
||||7.|Disposable Hypodermic Syringes|
|||||Class C|
||||8.|Blood Bag (Single Blood Bag,|
|||||Double Blood Bag, Triple Blood Bag,|
|||||Quad Blood Bag) Class C|
||||29.|Disinfectant (Excluding Bio-|
|||||compatibility testing)|
||12||Accuprec Research |TL/MD/2021/000002| 1. <br>Labs Private Limited||Vasculardevices and IVsets; Class<br>D|
|||Opp. Zydus Pharmez,<br>Changodar- Bavla<br>Highway, Vill-Matoda,,<br>Sanand, Ahmedabad,|2. <br>3. <br>4. <br>5.|Tubal rings; ClassC<br> CopperT; Class C<br> Sutures; ClassC<br> Disposable Hypodermic needles;|
|||Gujarat -382213|6.|ClassC<br>Catheters; Class D|
||||7.|DisposableHypodermicSyringes;|

|fy<br>7||||Class B<br>8.<br>Blood bags; Class B||
|---|---|---|---|---|---|
|||||9. Condoms; Class C||
|||||10. Coronary stents; Class D<br>11.Intra Ocular Lenses Implants; Class||
|||||D||
|||||12.Orthopaedic Implants and Devices;||
|||||Class D||
|||||13.Drug eluting stents; Class D||
|||||14. Internal Prosthetic replacements;||
|||||Class D||
|||||15.Ablation devices; Class D||
||13.||Mis, Conformity<br>Testing Labs Pvt Ltd<br>WH-52, Mayapuri<br>Industrial Area, Phase|TL/MD/2021/000003||1.NIBP; Class B<br>2.IBP; ClassC<br>3.Nebulizer; Class C<br>4.Thermometer; Class B||
|||1, New Delhi, West||5.Glucometer; Class B||
||14|Delhi, Delhi - 110064<br> |Brothers<br>Laboratories Pvt. Ltd|TL/MD/2021/000004||1.Disposable Hypodermic Needles;<br>Class B||
|||103, D-3, Industrial<br>Area Jhotwara, Jaipur,<br>Rajasthan -302012||2.Surgical Dressings; ClassA<br>3. Disposable perfusion set; Class B<br>4.Catheters; Class B<br>5.Surgical Dressings; Class B||
|||||6.Disinfectants; Class B||
|||||7.Disposable Hypodermic Syringe;||
|||||Class B||
|||||8.IV Canulae; Class B||
||15|een!<br> |M/s, Shiva<br>Analyticals (India)<br>Private Limited|TL/MD/2021/000005|9.Scalp Vein Set; Class B<br>|1. Cardiac Stents (Test- Ethylene<br>Oxide residue,<br>Standard/Specification-!SO|7|
|||situated at Plot Nos.||10993-7-2008) Class C, Class D||
|||24D (P) &34D,<br>KIADB Industrial||2. Catheters (Test- Ethylene Oxide<br>residue, Standard/Specification-ISO||
|||Area, Hoskote,<br>Bangalore, Hoskote,<br>Bengaluru<br>(Bangalore) Rural,<br>Karnataka - 562114||10993-7-2008) —Class A, B, C, D<br>3. Disposable Perfusion Sets (Test-<br>Ethylene Oxide residue,<br>Standard/Specification-ISO 10993-7-<br>2008) Class A, Class B, Class C||
|||||4. Drug Eluting Stents (Test- Ethylene||
|||||Oxide residue,||
|||||Standard/Specification-ISO-10993-||
|||||7-2008) Class D||
|||||5.<br>HeartValves (Test- Ethylene Oxide||
|||||residue, Standard/Specification-ISO||
|||||10993-7-2008) Class D||
|||||6.<br>Intra Ocular Lenses (Test- Ethylene||
|||||Oxide residue,||
||||10|||

.	oO

||||||||Standard/Specification-ISO 10993-7-<br>2008) Class C|
|---|---|---|---|---|---|---|---|
|||||||7.|IVCannula (Test- Ethylene Oxide|
||||||||residue, Standard/Specification-ISO|
||||||||10993-7-2008) Class B, Class C|
|||||||8.|Orthopaedic Implants (Test-|
||||||||Ethylene Oxide residue,|
||||||||Standard/Specification-ISO 10993-7-|
||||||||2008) Class B, Class C, Class D.|
|||||||9.|Scalp Vein Set (Test- Ethylene|
||||||||Oxide residue,|
||||||||standard/Specification-ISO10993-7-|
||||||||2008) Class B|
|||||||10.|Surgical Dressings (Test- Ethylene|
||||||||Oxide residue,|
||||||||tandard/Specification-ISO 10993-7-|
||||||||2008) Class A, Class B, Class C,|
||||||||Class D|
|||||||11.Disposable Hypodermic Needles||
||||||||(Test-Ethylene Oxide residue,|
||||||||Standard/Specification-ISO 10993-7-|
||||||||2008) Class B|
|||||||12.Disposable|Disposable Hypodermic Syringes|
||||||||(Test-Ethylene Oxide residue,|
|||||||Standard/Specification-ISO 10993-7-||
|||||||2008) Class B, ClassC||
|||||||13.Ablation Device (Test- Ethylene||
||||||||Oxide residue,|
||||||||Standard/Specification-ISO-10993-|
|16||M/s,|M/s, APEX QUALITY) <br>CERTIFICATION<br>SERVICES PVT. LTD.|||=<br> TL/MD/2021/000006||7-2008)<br>|1. Infusion/Syringe Pump ( Flow Rate,<br>Volume, Occlusion Pressure,<br>Electrical Safety) (Reference||
|||situated<br>at<br>161,<br>KASTURBA NAGAR,|||||Standard IEC 60601-2-24,<br>1S13450(Part2 Sec24)and IEC|
||||||||60601-1). Class C.|
|||NIRMAN|NAGAR,|||||
|||Jaipur,<br>Jaipur,<br>Rajasthan - 302019||||2.|Aspirator(Vacuum Testing,<br>Electrical Safety) (Reference|
||||||||Standard ISO 10079-1 and IEC|
||||||||60601-1) — Class C.|
|||||||3.|Glucometer (Glucose Concentration|
||||||||Testing) (Reference Standard|
||||||||IS/ISO 15197.2013) — Class C|
|||||||4.|Blood Pressure Monitoring Devices|
||||||||(Leak Test, NIBP Pressure|
||||||||Accuracy) (Reference Standard|
||||||||IEC60601-2-30. 2009) — Class B.|
|||||||5.|Nebulizer (Flow Rate, Aerosol|
||||||||Output, Aerosol! Output Rate,|
||||||||Electrical Safety)<br>(Reference|
||||||11|||

==> picture [551 x 701] intentionally omitted <==

----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|_%|Standard|1SO27427.2013 and|IEC|
|.|60601-1)|Class|C.|
|6.|Digital|Thermometer,|(Temperature|
|Testing)|(Reference|Standard|-|
|ISSO|80601-2-56.|2017|and|IS|
|3055|Part|1|and|Part|2|and|IS|6274|
|17|| M/s,|Shri|Ram|TL/MD/2021/000007|||1.|Tubal|Rings/Fallopian|Rings|
|Scientific And|(Shape,|Dimensions,|Fracture|
|Industrial|Research|Test,|Memory Test,|Friction|Force|
|:|Test,|Fatigue|Test,|Radio|Opacity,|
|-esneasen|Sterility,|Identification|of polymer)|
|Address:|8E,|Diamond|2.|Male|Latex Condoms|(Dimensions,|
|Press|Building,|Burst volume and|pressure|test,|
|Jhandewalan|Water Leakage|test,|Quantity|of|
|Extension,|Rani|lubricant,|Colour|Fastness,|Integrity|
|Jhansi|Road,,|Delhi,|of individual|package|seal,|
|New|Delhi,|Delhi|-|Labeling|packaging|and|storage)|
|410055|3.|COPPER-T 380A (Physical|
|Parameters|and|Dimensions,|
|Pouch|burst|strength,|Amt|of|
|copper wire,|Strength|of the|Tie,|
|Copper|collar|pull|force,|Sterility)|
|4.|Implantable|Medical|Devices|
|(Physical|Parameters|and|
|Dimensions,|Sterility|Test,|BET|
|Test,|Bio-Burden|Test)|
|5.|Implantable|Medical|Devices|
|(Physical|Parameters|and|
|Dimensions,|Sterility|Test,|BET|
|Test,|Bio-Burden|Test)|
|6.|!UCD-375|(Visual|Inspection,|
|||Sealed|Pouch|peel|strength,|Frame|
|||dimensions,|Copper|wire|weight,|
|Insertion|Tube|dimension,|Thread,|
|Flange|displacement|force,|
|Sterility)|
|7.|Disposable|Hypodermic|Needles|
|(Acidity|or Alkalinity,|Extractable|
|Metals,|Physical|Parameters|and|
|Dimensions,|Performance|Bond|-|
|Hub|and|Needle|tube,|Patency|of|
|lumen,|Sterility,|Bacterial|
|Endotoxin)|
|8.|Disposable|syringe|(Extraneous|
|matter,|Acidity|or|Alkalinity,|
|Extractable|Metals|Lubricant,|
|Physical|Parameters|and|
|Dimensions,|Sterility|Test,|Bacterial|
|Endotoxin)|
|9.|Disposable|syringe|(Extraneous|
|matter,|Acidity|or Alkalinity,|

----- End of picture text -----

==> picture [38 x 27] intentionally omitted <==

----- Start of picture text ----- {> _. ° ----- End of picture text -----

| |

Extractable Metals Lubricant, Physical Parameters and Dimensions, Sterility Test, Bacterial Endotoxin)
1. Surgical dressings (Threads, weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)
1. Surgical dressings (Threads, weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)
1. Surgical dressings (Threads, weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)
1. Sterile Hypodermic Syringe for Single use (Sterility Test, Bacterial Endotoxin Test)
1. Cardiac Stent (Sterility Test) 15. Cardiac Stent (Sterility Test) 46. Catheters (Dimensions, Sterility Test)
1. Catheters (Dimensions, Sterility Test)
1. Blood Bags (Sterility Test, BET, Chemical Analysis, Physical Dimensions)
1. Blood Bags (Sterility Test, BET, Chemical Analysis, Physical
1. Di menspo s ableions)Hypodermic Needles (Acidity or Alkalinity, Extractabie Metals, Physical Parameters and Dimensions, Performance Bond - Hub and Needle tube, Patency of lumen, Sterility, Bacterial Endotoxin)
1. Surgical dressings (Threads, weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)
1. Umbilical Tapes (Physical Test, Adhesive, Strength, Length dia)
1. Umbilical Tapes (Physical Test, Adhesive, Strength, Length dia)
1. IV Cannula (Dimensions, Sterility) 25. I\V Cannula (Dimensions, Sterility) 26. Copper-T (Sterility Test, Membrane Filtration Method)
1. Suture absorbable / Suture non-

|||>|||||||absorbable Synthetic (Sterility Test,|
|---|---|---|---|---|---|---|---|---|---|
|.|:||||||||Direct Inoculation Method)|
|||||||||28.|Tubal Ring (Sterility Test,|
||||||||||Membrane Filtration Method)|
||||_<br>18.||M/s,VIVO BIOTECH | <br>LTD|||TL/MD/2021/000008|| 1. <br>2.|Infusion Set Class B<br>Sutures Class|
||||||Address: 3 Floor, Ilyas<br>Mohammed Khan|||3. <br>4.|TranscatheterAortic Valve Class D<br> Tubal Ring Class C|
||||||Estate, D. No. 8-2-|||5.|Blood Collection Sets Class D|
||||||672/ 5 & 6, Road<br>No.1, Banjara Hills,<br>Hyderabad,|||6.<br>7.<br>8.|Blood Bags Class<br>Intraocular Lens ClassC<br> Orthopedic Implants Class|
||||||Telangana - 500034|||||
||||19||M/s, Conformity<br>Testing Labs Pvt Ltd<br>Address: WH-52,||TL/MD/2021/000009|| 1. <br>2. <br>3.|CTscan Equipment<br> MRI Equipment<br>Defibrillators|
||||||Mayapuri Industrial<br>Area, Phase 1, New|||4. <br>5.|BoneMarrow cell separator<br> PET Equipment|
||||||Delhi, West Delhi,|||6.|X-Ray Equipment|
||||20|||Delhi - 110064<br> Mis, OasisTest<br>House Limited|_|TL/MD/2022/000001|7. <br> | 1. <br>2.|DialysisMachine<br> Orthopaedic Implants<br>Intraocular lens|
||||||situated at SP-2, 22|||3.|Catheter classA|
||||||Godam Industrial|||4.|Bone cement|
||||||Estate, Jaipur-<br>302006.<br>, Jaipur,<br>Jaipur, Rajasthan -<br>302006|||5. <br>6. <br>7. <br>8.|Blood bags<br> Catheter Class B<br> Disposable Hypodermic Needles<br> Disposable Perfusion Sets|
|||||||||9.|Disposable Hypodermic Syringes|
|||||||||10.IV Cannulae||
|||||||||||11.Scalp Ven Set||
||||||||||12. surgical dressings||
|||||||||13. Sutures and Ligatures||
||||21||M/s,|7<br>M/s, OasisTest<br>House||oe<br>TL/MD/2022/000003|14.Intrauterine Device<br> | 1. Catheters - ClassA<br>2.<br>Intra Ocular Lenses - ClassC||
||||||situated at24A-B,<br>Sardar Patel Industrial|||3. <br>4.|Orthopedic Implants -Class C<br> Surgical Dressings - Class B|
||||||Estate, Narol,<br>Ahmedabad, Gujarat<br>- 382405|||5. <br>6. <br>7.|Orthopedic Implants - Class D<br> Scalp vein set - Class B<br>Disinfectants - Class B|
|||||||||8.|Infusion sets - Class B|
|||||||||9.|Blood bags - Class C|
|||||||||10.Catheters|Catheters - Class B|
|||||||||11.Disp Hypodermic Needles-Class B||
|||||||||12.Disposable|Disposable Perfusion Sets-Class B|
|||||||||13.|Disp Hypodermic Syringes-Class B|
|||||||||14.Disposable|Disposable Perfusion Sets- classA|
|||||||||15.1V Cannulae - Class B||
||||||||TL/MD/2022/000004|1.||X-rayEquipmentforRadiography|

: :

7 Ltd., and Radioscopy — Class C 2. Cardiac Defibrillators — Class C Sr. No. 82/1, Bajirao 3. Invasive Blood Pressure Monitoring Dhawade Patil Equipment - Class C Industrial Estate, NDA 4. Mammographic X-ray Equipment Road, Shivane, Pune, and Mammographic Stereotactic Maharashtra - 411023 Devices - Class C 5. Peritoneal Dialysis Equipment - Class C 6. Ultrasonic Medical Diagnostic and Monitoring Equipment - Class B 7. X-ray Equipment for Interventional Procedures - Class C 23 | M/s INSTITUTE FOR TL/MD/2022/000005 | 1. Foley Catheter Two way (Test INDUSTRIAL Parameter BET and Sterility) - Class RESEARCH & D TOXICOLOGY 2. DISPOSABLE ELECTRODE RECORDING CATHETER (Test F209PHASE 4, UPSIDC, Parameter-BET and Sterility) - Class M.G. ROAD, D Ghaziabad, Uttar 3. INTRODUCER SHEATH Pradesh, 201001 CATHETER (Test Parameter-BET Ghaziabad (India) - and Sterility) - Class D 245101 4. DOUBLE LUMEN CATHETER SET (Test Parameter-BET and Sterility) - Class D 5. DISPOSABLE CENTRAL VENOUS CATHETER (Test Parameter-BET and Sterility) - Class D 6. DOLPHIN SUTURES (Test ' parameter Sterility) - Class C 7. DISPOSABLE EMBOLECTOMY CATHETER (Test Parameter-BET and Sterility) - Class D 8. DISPOSABLE THERMODILUTION CATHETER (Test Parameter-BET and Sterility) - Class D 9. Foley Catheter Two way (Test Parameter BET and Sterility) -Class B 10. Male Catheter (Test ParameterBET and Sterility) - Class B 11. Ryles Tube 14FG_ (Test Parameter-BET, Bioburdan and Sterility) - Class B 12. | Endotracheal tube (Test Parameter-BET, Bioburdan and Sterility) - Class B 13. Coronary Artery Cannula (Test Parameter-BET and Sterility) - Class B

. ,

*

||||||||14.<br>Natural<br>rubber<br>latex<br>condom<br>(Test Parameter-BET ) - Class B|14.<br>Natural<br>rubber<br>latex<br>condom<br>(Test Parameter-BET ) - Class B|
|---|---|---|---|---|---|---|---|---|
||||||||15.|Urethreal<br>Catheter<br>(Test|
||||||||Parameter-BET and Sterility) -Class||
||||||||D||
||||||||16.|Multiple Lumen Catheter<br>(Test|
||||||||Parameter-BET and Sterility) -Class||
||||||||B||
|24||||MlsVorickAnalytical <br>Research Pvt. Ltd.||||TL/MD/2022/000006|1.|Lint Bandage<br>- Dimensions, pH<br>Value,<br>Scouring<br>Loss, Freedom|
|||||||||from optical Witness ClassA|
||||Plot No. 252, Sector—<br>K, Bhorgarh Industrial<br>Area, Bawana -— Il,<br>Narela, North Delhi,<br>Delhi (India)<br>- 110040||||2. <br>3.|Heart Valves - Heavy toxic metals<br>as<br>Arsenic,<br>lead,<br>Cadmium,<br>Mercury<br>Particulate<br>Contamination, Sterility Class D<br> Disposable<br>Perfusion<br>set<br>-<br>Particulate contamination, Tubing|
|||||||||length, Flow rate, Heavy Metals,|
|||||||||Acidity or<br>alkalinity, Residue on|
|||||||||evaporation,<br>UV<br>absorption<br>of|
|||||||||extract solution, Sterility Class B|
||||||||4.|Heavy toxic metals as Arsenic,|
|||||||||lead,<br>Cadmium,<br>Mercury,<br>Particulate<br>Contamination,|
|||||||||Mercury Class D|
||||||||5.|Ablation<br>Devices<br>-Heavy<br>toxic|
|||||||||metals<br>as<br>Arsenic,<br>lead,|
|||||||||Cadmium,<br>Mercury,<br>Particulate|
||||||||||6.<br>7.|Contamination, SterilityClassC<br>Ablation<br>Devices-<br>Heavy<br>toxic<br>metals<br>as<br>Arsenic,<br>lead,<br>Cadmium,<br>Mercury,<br>Particulate<br>Contamination, Sterility Class D<br>Cardiac<br>Stents<br>-<br>Heavy<br>toxic|
|||||||||metals<br>as<br>Arsenic,<br>lead,<br>Cadmium,<br>Mercury,<br>Particulate|
|||||||||Contamination, Sterility Class D|
||||||||8.|Disposable Hypodermic Syringe -|
|||||||||Capacity, Fiducial Line, Limits for|
|||||||||acidity<br>or<br>alkalinity,<br>Metal,|
|||||||||Lubricant,<br>Scale,<br>Barrel,<br>Piston,|
|||||||||Nozzle,<br>Performance,<br>Reducing|
|||||||||substances, Sterility Class B|
||||||||9.|Bone<br>Cements-Heavy __ toxic|
|||||||||metals<br>as<br>Arsenic,<br>lead,|
|||||||||Cadmium, Mercury, Sterility Class|
|||||||||C|
||||||||10.|Contraceptives-<br>Heavy<br>toxic|
|||||||||metals<br>as<br>Arsenic,<br>lead,|
|||||||||Cadmium,<br>Mercury,<br>Water|
|||||||||Leakage<br>test,<br>Bursting<br>volume|
|||||||16|||

==> picture [551 x 701] intentionally omitted <==

----- Start of picture text ----- ft and pressure test, dimension, ._ Sterility Class C 11. Contraceptives- Heavy toxic metals as__ Arsenic, lead, Cadmium, Mercury, Water Leakage test, Bursting volume and pressure test, dimension, Sterility Class D 12. Disinfectant-Efficacy Test Class B 13. Disposable Hypodermic Needles - Limits for acidity or alkalinity, Limits for extractable metals, Size designation, Colour coding, Needle hub, tube, point, Sheath, Performance, Sterility Class B 14. IVD Kits - Sterility Class B 15. IVD Kits - Sterility Class C 16. IVD Kits - Sterility Class D 17. Blood Bags - Length, Width, Diameter, Leakage test, Limit of acidity or alkalinity, Heavy toxic metals as Arsenic, lead, Cadmium, Mercury, Sterility Class Cc 18. Disposable Hypodermic Needles - Limits for acidity or alkalinity, Limits for extractable metals, Size designation, Colour — coding, Performance, Sterility Class C | 49. NeedleInternal hub,Prosthesistube, point,- HeavySheath,toxic | | metals as Arsenic, lead, Cadmium, Mercury Particulate Contamination, Sterility Class D 20. IV Cannula - Limits for acidity or alkalinity, Intravascular Catheter, Distal end, Hub, Effective length, Outside Diameter, Corrosion Test, Peak tensile force, Freedom from leakage, Sterility Class C 21. Surgical Dressing-Bleached Gauze, Length, Width, Weight in gm/m2, Scouring loss/Foreign matter, Absorbency, Freedom from optical Whitness, pH value of aqueous extract, Sterility Class A 22. Orthopedic Implants- Heavy toxic metals as Arsenic, lead, Cadmium, Mercury, Particulate Contamination, Sterility Class D 23. Surgical Dressing IHS/ As_ per ----- End of picture text -----

==> picture [37 x 25] intentionally omitted <==

----- Start of picture text ----- . aa, , ----- End of picture text -----

||manufacturer specifications Class<br>D||
|---|---|---|
|24.|Internal Prosthesis - Heavy toxic||
||metals<br>as<br>-<br>Arsenic,<br>lead,||
||Cadmium,<br>Mercury<br>Particulate||
||Contamination, Sterility Class C||
|25.|Disposable<br>Perfusion<br>set<br>-||
||Particulate contamination, Tubing||
||length, Flow rate, Heavy Metals,||
||Acidity or alkalinity,<br>Residue on||
||evaporation,<br>UV<br>absorption<br>of||
||extract solution, Sterility ClassA||
|26.|Surgical<br>Dressing<br>-<br>Bleached||
||Gauze, Length, Width, Weight in||
||gm/m2,<br>Scouring<br>loss/Foreign||
||matter,<br>Absorbency,<br>Freedom||
||from optical Whitness, pH value of||
||aqueous extract, Sterility Class C||
|27.|IV Cannula - Limits for acidity or||
||alkalinity,<br>Intravascular Catheter,||
||Distal end, Hub, Effective length,||
||Outside Diameter, Corrosion Test,||
||Peak tensile force, Freedom from||
||leakage, Sterility Class B||
|28.|Crepe Bandages<br>-<br>Dimensions,||
||Weight<br>per<br>unit<br>area,<br>Stretchability,<br>|breaking<br>load,||
||Chemical Neutrality. ClassA||
|29.|POP Bandages<br>- Setting Time,||
||Tensile<br>Strength,<br>Compressive||
||strength ClassA|||
|30.|Disposable<br>Perfusion<br>set<br>-||
||Particulate contamination, Tubing||
||length, Flow rate, Heavy Metais,||
||Acidity or alkalinity,<br>Residue on||
||evaporation,<br>UV<br>absorption<br>of||
||extract solution, Sterility Class C||
|31.|Catheters-<br>Length,<br>Diameter,||
||Heavy toxic metals as Arsenic,||
||lead,<br>Cadmium,<br>Mercury,||
||Particulate Contamination, Sterility||
|32.|ClassA<br>Catheters-<br>Length,<br>Diameter,||
||Heavy<br>toxic metals as Arsenic,||
||lead,<br>Cadmium,<br>Mercury,||
||Particulate Contamination, Sterility||
||Class B||
|33.|Catheters-<br>Length,<br>Diameter,||
||Heavy toxic metals as Arsenic,||
||lead,<br>Cadmium,<br>Mercury,||
||ParticulateContamination,Sterility||

|.|7|5||||34.|Class C<br>Catheters-<br>Length,<br>Diameter,|
|---|---|---|---|---|---|---|---|
||||||||Heavy toxic metals as Arsenic,|
||||||||lead,<br>Cadmium,<br>Mercury,|
||||||||Particulate Contamination, Sterility|
|||||||35.|ClassD<br>Orthopedic Implants- Heavy toxic|
||||||||metals<br>as<br>Arsenic,<br>lead,<br>Cadmium,<br>Mercury,<br>Particulate|
||||||||Contamination, Sterility Class C|
|||||||36.|Surgical<br>Dressing<br>-<br>Bleached|
||||||||Gauze, Length, Width, Weight in|
||||||||gm/m2,<br>Scouring<br>loss/Foreign|
||||||||matter,<br>Absorbency,<br>Freedom|
||||||||from optical Whitness, pH value of|
||||||||aqueous extract, Sterility Class B|
|||||||37.|Disposable Hypodermic Syringe -|
|||||||||Capacity, Fiducial Line, Limits for<br>acidity<br>or<br>alkalinity,<br>Metal,|
||||||||Lubricant,<br>Scale,<br>Barrel,<br>Piston,|
||||||||Nozzle,<br>Performance,<br>Reducing|
||||||||substances, Sterility Class B|
|||||||38.|Rolled Bandage - Dimensions, pH|
||||||||Value,<br>Scouring<br>Loss,<br>Freedom|
|||||||_____|from opticalWitness ClassA|
||||25.|||M/s, TUVRheinland |TL/MD/2022/000007| <br>(India) Pvt. Ltd.,<br>situated atSurvey No<br>480/2,AMTZ<br>Campus, Nadupuru<br>Village,<br>Pedagantyada,<br>Pragati Maidan,<br>Visakhapatnam,<br>Andhra Pradesh-<br>530031|1. <br>2.<br>3. <br>4.|Medical<br>Electrical<br>Equipments-<br>IEC/EN 60601-1/IS 13450 (Part 1)<br>ClassA<br>Electrical<br>Safety Testing<br>- Puise<br>Oximeter,<br>Oxygen<br>Concentrator,<br>Electrocardiograph ClassC<br> Electro Magnetic Interference and<br>Electro<br>Magnetic<br>Compatibility<br>(EMVEMC)<br>-<br>Electro<br>Medical<br>Equipments Class C<br> Personal<br>Protectives<br>(Coverall,<br>Surgical<br>Masks,<br>Filter<br>type<br>Particulate<br>Matter<br>Respirator,|
||||||||Medical<br>Textile,<br>Face<br>Mask,|
||||||||Surgical<br>Gowns<br>and_<br>Surgical|
||||||||Drapes) ClassA|
|||||||5.|Personal<br>Protectives<br>(Coverall,|
||||||||Surgical<br>Masks,<br>Filter<br>type|
||||||||Particulate<br>Matter<br>Respirator,|
||||||||Medical<br>Textile,<br>Face<br>Mask,|
||||||||Surgical<br>Gowns<br>and _<br>Surgical|
||||||||Drapes) Class B|
|||||||6.|Bioburden<br>Testing<br>(Disposable|
||||||||Hypodermic<br>Needles,<br>Surgical|
||||||||Dressings, Medical Textile) ClassA|
|||||||7.|In<br>-<br>Vitro<br>Cytotoxicit<br>Test|
||||||19|||

|||~|||||(Disposable<br>Hypodermic<br>Needles,|
|---|---|---|---|---|---|---|---|
|.|.||||||Surgical Dressings, Medical Textile)|
|||||||8.|ClassA<br>Electrical<br>Safety<br>Testing<br>-<br>Pulse|
||||||||Oximeter,<br>Oxygen<br>Concentrator,|
||||||||Electrocardiograph Class B|
|||||||9.|Electro Magnetic Interference and|
||||||||Electro<br>Magnetic<br>Compatibility|
||||||||(EMVEMC)<br>-<br>Electro<br>Medical|
||||||||Equipments ClassA|
|||||||10.Electrical<br>Safety<br>Testing<br>-<br>Pulse||
||||||||Oximeter,<br>Oxygen<br>Concentrator,|
||||||||Electrocardiograph Class A|
|||||||11.Electro Magnetic Interference and||
||||||||Electro<br>Magnetic<br>Compatibility|
||||||||(EMI/EMC)<br>-<br>Electro<br>Medical|
||||||||Equipments Class B|
|||||||12.Bioburden<br>Testing<br>(Disposable||
||||||||Hypodermic<br>Needles,<br>Surgical|
||||||||Dressings, Medical Textile) Class B|
|||||||13.Medical<br>Electrical<br>Equipments-||
||||||||IEC/EN 60601-1/IS 13450 (Part 1)|
||||||||Class B|
|||||||14.Medical<br>Electrical<br>Equipments-||
||||||||IEC/EN 60601-1/S 13450 (Part 1)|
||||||||Class C|
|||||||15.In-Vitro<br>Cytotoxicity<br>Test<br>(Disposable<br>Hypodermic<br>Needles,<br>Surgical Dressings, Medical Textile)||
||||26.||M/s,SHREEBALAJI |TL/MD/2022/000008| 1. <br>TESTLAB PVT. LTD.|||Class B -<br>_<br> Surgical<br>Gloves<br>(Physiochemical,<br>BET and Sterility) ClassA|
|||||||2.|Disinfectant Class B|
|||||situated at||3.|Catheters<br>(Physiochemicai,<br>BET|
|||||C-181, NARAINA<br>INDUSTRIALAREA||4.|and Sterility) Class C<br>Cardiac Stents (BET and Sterility)|
|||||PHASE-1<br>- 110028|, New Delhi|5.|Class D<br>Disposable<br>Hypodermic<br>Needles<br>(Physiochemical, BET and Sterility)|
||||||||Class B|
|||||||6.|Blood Bags (Physiochemical, BET|
||||||||and Sterility) Class C|
|||||||7.|Surgical<br>Dressings|
||||||||(Physiochemical, BET and Sterility)|
||||||||Class B|
|||||||8.|Scalp Vein Sets (Physiochemical,|
||||||||BET and Sterility) Class B|
|||||||9.|Face<br>Mask<br>(BET<br>and_<br>Sterility)|
|||||||ClassA<br>10. Orthopedic<br>Implants||
||||||||Physiochemical,BETandSterilit|

. 7

||||Class C|
|---|---|---|---|
|||11.Disposable<br>Hypodermic<br>Syringe||
||||(Physiochemical, BET and Sterility)|
||||Class B|
|||12.|Disposable<br>Perfusion<br>Sets|
||||(Physiochemical, BET and Sterility)|
||||Class B|
|||13.|Surgical Sutures<br>(Physiochemical,|
||||BET and Sterility) Class C|
|||14.1.V Cannula (Physiochemical, BET||
||||and Sterility) Class B|
|27.||M/s, INTERSTELLER| TL/MD/2022/000009 | 1. <br>TESTING CENTRE||Suprapubic<br>or<br>non<br>disposable<br>cannula<br>(Test parameter-<br>Sterility|
||PVT. LTD.||and BET) Class B|
|||2.|Disposable<br>Hypodermic<br>needles|
||situated at 86,||(Test parameter- Sterility and BET)|
||Industrial Area, Phase<br>4, Panchkula,<br>Haryana - 134109|3.|Class B<br> NasogastricTube/ RylesTube (Test<br>parameter- Sterility and BET) Class<br>B|
|||4.|Disposable<br>perfusion<br>set<br>(Test|
||||parameter Sterility and BET) Class|
||||B|
|||5.|Feeding<br>Tube<br>(Test<br>parameter-|
||||Sterility and BET) Class B|
|||6.|Gastrointestinal<br>Tube<br>(Test|
||||parameter Sterility and BET) Class|
||||B|
|||7.|Gastro-Enterostomy<br>Tube<br>(Test|
||||parameter- Sterility and BET) Class|
||||B|
|||8.|Bolster<br>Suture<br>(Test<br>parameter-|
||||Sterility and BET) ClassA|
|||9.|Blood<br>Transfusion<br>set<br>(Test|
||||parameter Sterility and BET) Class|
||||B|
|||10.Urinary<br>Drainage<br>Unit<br>(Test||
||||parameter Sterility and BET) Class|
||||B|
|||11. Upper Urinary tract catheter (Test||
||||parameter- Sterility and BET) Class|
||||B|
|||12.Foley<br>Catheter<br>(Test<br>parameter-||
||||Sterility and BET) Class B|
|||13.Coude<br>catheter<br>(Test<br>parameter-||
||||Sterility and BET) Class B|
|||14. Alcohol<br>Swabs<br>(Test<br>parameter-||
||||Sterility and BET) ClassA|
|||15. Surgical Dressing (Test parameter||
||||Sterility and BET) ClassA|
|||16.Nasopharyngeal<br>Catheter<br>est||

==> picture [499 x 701] intentionally omitted <==

----- Start of picture text ----- parameter- Sterility and BET) Class A 17.Disposable Hypodermic Syringe (Test parameter- Sterility and BET) Class B 18. Contraceptives (Test parameter- Sterility and BET) Class C 19. Intraocular lenses (Test parameter Sterility and BET) Class C 20. Surgical stapler (Test parameter- Sterility and BET) Class B 21. Orthopaedic implants (Test parameter Sterility and BET) Class B 22. Internal Prosthetic placements (Test || parameter-Cc Sterility and BET) Class 23. Ablation device (Test parameter- Sterility and BET) Class C 24. IV cannula (Test parameter- Sterility 28. | M/s, Yadav TL/MD/2022/000010 | ___1. andMedicalBET) ClassElectricalB Equipments Measurements (EN/IEC 60601-1-2) Class A | Private Limited 2. In Vitro Diagnostic (IVD) Medical Electrical equipments (IEC 61326- situated at 2-6) Class A Plot No 373-375, 3. In Vitro Diagnostic (IVD) Medical RIICO Bhamashah Electrical equipments (IEC 61326- Industrial Area , 2-6) Class C Kaladwas, Udaipur, 4. Electro Magnetic Interference and Rajasthan, India- Electro Magnetic Compatibility 313003 (EMI/EMC)-Electro Medical and IVD Equipments (Basic Standard) Class A 5. Electro Magnetic Interference and Electro Magnetic Compatibility (EMI/EMC)-Electro Medical and IVD Equipments (Basic Standard) Class Cc 6. Medical Electrical Equipments (EN/IEC 60601-1-2) Class C 7. In-Vitro Diagnostic (IVD) Medical Electrical equipments (IEC 61326- 2-6) Class B 8. Electro Magnetic Interference and Electro Magnetic Compatibility (EMI/EMC)-Electro Medical and IVD Equipments (Basic Standard) Class B 9. Medical Electrical Equipments EN/IEC 60601-1-2) Class B ----- End of picture text -----

29 | M/s Bharat Test TL/MD/2022/00001 1 1. Ultrasonic Physiotherapy . House Private Equipments Class B Limited 2. Surgical Luminaires _ - and Luminaires for Diagnosis Class 109, Anupam A Bhawan, Azadpur 3. Operating Tables Class C Commercial Complex 4. Ultrasonic Physiotherapy Delhi, North West Equipments Class C Delhi, Delhi (India) - 5. Ultrasonic Physiotherapy 110033 Equipments Class D 6. Baby Incubators Class A 7. Baby Incubators Class B 8. Baby Incubators Class C 9. Baby Incubators Class D 10. Ultrasonic Physiotherapy Equipments Class A 11.Medical Electrical Equipments Class A 12.Operating Tables Class A 13. Surgical Luminaires and Luminaires for Diagnosis Class Cc 14.Medical Electrical Equipments Class B 15.Medical Electrical Equipments Class C 16.Medical Electrical Equipments Class D 17.Operating Tables Class B | | 18.Operating Tables Class D | 19. Surgical Luminaires and | Luminaires for Diagnosis Class B 20. Surgical Luminaires and Luminaires for Diagnosis Class D 30 | M/s Manisha TL/MD/2022/000012 1. Sterile Blood Bags Class A Analytical 2. Sterile Catheters Class B Laboratories Pvt. 3. Disposable Hypodermic Needles Ltd. Class B 4. Disposable Perfusion Set Class situated at 135-A, B Govt. Industrial 5. |.V Cannula Class B Estate, Charkop, 6. Orthopedic Implants Class C Kandivali West, 7. Contraceptives Devices (Tubal Mumbai, Maharashtra Rings, Condoms) Class C - 400067 8. Intraocular lens Class C 9. Surgical Dressings Class B 10.Cardiac Stents and Drug Eluting | Stent Class D 11.Heart Valve Class D | 23

|||||||||12.Disposable|Disposable<br>Hypodermic|
|---|---|---|---|---|---|---|---|---|---|
|.|:||||||||Syringes Class B|
|||||||||13.Surgical Sutures and Ligatures||
||||||||||ClassC|
||||31||M/s.VIRIDIAN<br>TESTING|TL/MD/2023/000001|||1.|Medical devices (Surgical face<br>masks/Medical<br>Face<br>mask,|
|||||LABORATORIES<br>LLP|||||Respiratory<br>Productive<br>device/Particle<br>Filtering<br>Half|
||||||||||mask<br>or<br>Respirators,<br>Surgical|
|||||situated at D/No 3/244|||||N95 Respirators, Surgical Gown|
||||||A, NEARAVP<br>SCHOOL,<br>AATHUPALAYAM,<br>CHETTIPALAYAM<br>PANCHAYAT,<br>PONGUPALAYAM(P<br>O), TIRUPUR, Tamil<br>Nadu -641666||||2.|and<br>Surgical<br>Drape)<br>testing<br>ClassA<br> Medical devices (Surgical face<br>masks/Medical<br>Face<br>mask,<br>Respiratory<br>Productive<br>device/Particle<br>Filtering<br>Half<br>mask<br>or<br>Respirators,<br>Surgical<br>N95 Respirators, Surgical Gown<br>and<br>Surgical<br>Drape)<br>testing|
|||||||||3.|ClassB<br>Bioburden’<br>testing<br>(Medical|
||||||||||devices,<br>Medical<br>textiles<br>and|
||||||||||protective textiles) Class A|
|||||||||4.|Medical Devices<br>(Coverall<br>/Bio|
||||||||||protective<br>Coverall,<br>|solation|
||||||||||Gown,<br>Scrub<br>suit,<br>Cap,<br>Shoe|
||||||||||cover, Medical textile, protective|
||||||||||textiles,<br>Bedsheet<br>and<br>pillow|
||||||<br>|||||<br>||5.<br>6.|cover)testingClassB<br>Bioburden_<br>testing<br>(Medical<br>devices, Med**i**cal<br>textiles and<br>protective text les) Class B<br>Medical Devices<br>(Coveraii /Bio|
||||||||||protective<br>Coverall,<br>isolation|
||||||||||Gown,<br>Scrub<br>suit,<br>Cap,<br>Shoe|
||||||||||cover, Medical textile, protective|
||||||||||textiles,<br>Bedsheet<br>and<br>pillow|
||||32||<br> |M/s, HLLLifecare<br>Limited||oe<br>TL/MD/2023/000002||__<br>1. <br>2.|cover) testing ClassA<br> Activated-Oxygen<br>Generator<br>Class B<br>Bulk<br>Oxygen<br>Concentration|
|||||situated at Corporate<br>Head Office, HLL<br>Bhavan, Poojappura,<br>Thiruvananthapuram,<br>Kerala - 695012|,|||3. <br>4.<br>5. <br>6.|System ClassA<br> Foetal Pulse OximeterClass B<br>InfantApnoea MonitorClass B<br> Nitrogen<br>Monoxide<br>Analyser<br>Class B<br>Nitrous Oxide Analyser Class B|
|||||||||7.|Respiratory Apnoea<br>Monitoring|
||||||||||System Class B|
|||||||||8.|Stress TestTreadmill ClassA|
|||||||||9.|Whole-Body<br>Plethysmograph|

	Class B
	10.Diagnostic Spirometer Class B<br>.
	11.Oxygen Concentrator Class B
	12.Pulmonary<br>Function<br>Analysis
	System Class B
	13.ENT Chair, Electric Class A
	14.High-Frequency<br>Hyperthermia
	System Class C
	15.Powered Patient Table Class B
	16.Powered<br>X-Rays<br>Radiation
	Therapy Table Class B
	17.X-Ray<br>CT<br>System<br>For
	Radiotherapy Planning Class C
	18.Patient<br>Positioning<br>System,
	Ultrasound Class C
	19.Perimeter ClassA
	20.Keratoscope Class B
	21.Anesthesia Machine Class C
	22.Carbon Dioxide Monitor Class C
	23.High-Frequency Ventilator Class
	Cc
	24.\Intracardiac Oximeter Class B
	25.Oxygen<br>Saturation/Pulse<br>Rate
	Simulator Class A
	26. Pulse Co-Oximeter Class B
	27.Pulse Oximeter Class C
	28.Respiratory<br>Oxygen<br>Monitor
‘	Class B
	29.Ultrasonic Respiratory Humidifier
	Class B
	30.Cardiac<br>Monitor<br>(Including)
	Ciass B
	31.Echocardiograph Class B
	32.Electrocardiograph Class B
	33. Dental Suction System Class B
	34.Dental<br>Anesthesias<br>System
	Class C
	35.Electrosurgical<br>Cutting<br>and
	Coagulation Device Class C
	36.General<br>Electrosurgical<br>Unit
	Class C
	37.Powered Dermatome Class B
	38.Diagnostic X-Ray Beam-Limiting
	Device Class C
	39.Diagnostic X-Ray High Voltage
	Generator Class A
	40.Mammographic<br>X-Ray<br>System
	Class C
	41. Foetal Cardiac Monitor Class C
	42. Foetal Doppler System Class C
	43.General-Purpose<br>Ultrasound

==> picture [238 x 14] intentionally omitted <==

----- Start of picture text ----- | 25 ----- End of picture text -----

==> picture [11 x 12] intentionally omitted <==

----- Start of picture text ----- . . ----- End of picture text -----

==> picture [31 x 33] intentionally omitted <==

----- Start of picture text ----- | | ----- End of picture text -----

Imaging System Class B 44. Chair, Haemodialysis, Electrically Powered/Manual. Class A 45. Electroencephalogram (EEG) Signal Spectrum Analyzer. Class B 46. Electroencephalograph Test Signal Generator. Class B 47.Electroencephalograph _ Tester Class A 48.Electroencephalograph. Class C 49. Electroencephalographic Monitoring System Class C 50. Electromyograph Class B 51.Neurosurgical Microscope Class B 52.Electronic Monitor for Gravity Flow Infusion Systems Class C 53. Patient Scale Class A 54. Apgar Timer. Class A 55. Blood Bank Centrifuge Class A 56. Blood Storage Refrigerator Class B 57.Heat-Sealing Device Class A 58. Neonatal Intensive-Care Ventilator Class C 59.Neonatal Physiologic Monitoring System Class C 60. Neonatal/Paediatric Heart Rate Monitoring Hardware Class C 61.Pulmonary Function Analysis System, Paediatric Class B | 62. Deep-Tissue Electromagnetic Stimulation System Class B 63.Electromechanical Orthopaedic Extracorporeal Shock Wave Therapy System Class C 64.Birthing Bed/Table, Powered Class A 65. Cardiotocograph Class C 66. Infant Apnoea Monitor Class C 67.Infant Incubator Control Unit Class C 68. Infant Incubator Warming Hood Class A 69. Neonatal CPAP Unit Class C 70. Syringe Pump Class C 71. Open Infant Incubator Class C 72. Oxygen Breath Analyser Class C 73.Arthritis TENS System Class B

==> picture [12 x 9] intentionally omitted <==

----- Start of picture text ----- 26 ----- End of picture text -----

. .

|||||74.Interferential<br>Electrical|
|---|---|---|---|---|
|||||Stimulation System Class C|
|||||75.Medium-Wave<br>Diathermy|
|||||Treatment System Class B|
|||||76.Microwave Diathermy Treatment|
|||||System Class B|
|||||77.Musculoskeletal<br>Infrared|
|||||Phototherapy Unit Class B|
|||||78. Musculoskeletal<br>Intense|
|||||Therapeutic Ultrasound System|
|||||Class C|
|||||79.Short-Wave<br>Diathermy|
|||||Treatment System Class C|
|||||80.Chest X-Ray<br>Computer Aided|
|||||Detection Class B|
|||||81.Cystometer Class B|
|||||82.Electrohydraulic<br>Lithotripsy|
|||||System Class B|
|||||83.Electromechanical<br>Lithotripsy|
|||||System, Extracorporeal Class B|
|||||84.Electromechanical<br>Lithotripsy|
|||||System, Intracorporeal Class B|
|||||85.Intracorporeal Lithotripsy Suction|
|||||System Class B|
|||||86.Laser Lithotripsy System Class|
|||||C|
|||||87.Male<br>Urinary Outflow Analysis|
|||||___ System Class C_|
|33|7<br>||M/s BEE PHARMO<br>LABS PVT LIMITED|TL/MD/2023/000003|1.<br>Sterile Blood Bags ClassA<br>2.<br>Sterile Catheters Class B|
|||||3.<br>Disposable Hypodermic Needles|
|||| situated at219,<br>ASHIRWAD INDL.||Class B<br>4.<br>Disposable<br>Hypodermic|
|||ESTATE NO. 3,2ND||Syringes Class B|
|||FLOOR, RAM||5.<br>Disposable Perfusion Set Class|
|||MANDIR ROAD,||B|
|||GOREGAONWEST,||6.<br>Surgical Sutures and Ligatures|
|||Mumbai City,<br>Maharashtra -400104||ClassC<br>7. Orthopedic Implants Class C|
|||||8.<br>Contraceptives<br>Devices<br>(Tubal|
|||||Rings, Condoms) ClassC|
|||||9.<br>Surgical Dressings Class B|
|||||10.1.V Cannula Class B|
|||||11.Heart Valve Class D|
|||||12. |ntraocular lens Class C|
|||||13.Cardiac Stents and Drug Eluting|
|||;||Stent Class D|
|34|||M/sQVC<br>Certification<br>Services Private|TL/MD/2023/000004|1.<br>Aspirator<br>2.<br>CTScan Equipment<br>3.<br>Nebulizer|
|||Limited||4.<br>Ablation Devices|
||||27||

|||||||5.|X-Ray Equipment|||
|---|---|---|---|---|---|---|---|---|---|
|.|.|||||6.|Motorised Wheeled|||
|||||situated at 2-B CIVIL||7.|AcceleratorSystem Chair|||
|||||LINES YUKTI||8.|Ethylene oxide gas|||
|||||BUSINESS CENTRE||9.|Bed/chair electric massager|||
|||||NEAR OLD SESSION||10.|Patient Monitor|||
|||||COURT||11.|Dental Chair|||
|||||||12.|Surgical Light System|||
|||||||13.|Steam sterilizer.|||
|||||||14.|Dry-heat sterilizer. (Autoclave)|||
|||||||15.|Environmental<br>chamber _||for|
||||||||storage of platelet Concentrate|||
|||||||16.|Blood bank centrifuge|||
|||||||17.|Dialysis machine|||
|||||||18.|Electrocradio Graph|||
|||||||19.|Oxymeter|||
|||||||20.|Oxygen Concentrator|||
|||||||21.|Electrical ICU bed|||
|||||||22.|Electric Operating Table|||
|||||||23.|Medical bassinet|||
|||||||24.|Medical<br>examination|light,|AC|
||||||||powered or Battery|||
|||||||25.|Defibrillators|||
|||||||26.|MRI Equipment|||
|||||||27.|Blood storage refrigerator|||
|||||||28.|ENT surgical microscope|||
|||||||29.|Infusion/Syringe Pump|||
||||||||30.|Medical Electrical Equipment__|||
|||35||Mls.|Mls.AIC-AMTZ<br>Medivalley<br>Incubation Council|TL/MD/2023/000008|1.|Electro<br>Medical<br>Devices-EMC<br>Test<br>(Conducted<br>RF<br>Susceptibility)|||
|||||||2.|Electro<br>Medical<br>Devices-EMC|||
|||||situated atAMTZ|||Test (Electrical FastTransient)|||
|||||Administrative<br>Building, AMTZ||3.|Electro<br>Medical<br>Devices-EMC<br>Test (Surge Immunity)|||
|||||Campus, Pragati||||||
|||||Maidan, VM Steel||||||
|||||ProjecS.O.||||||
|||36||M/s.|Visakhapatnam, AP<br>M/s.Vardan<br>envirolab|TL/MD/2023/000009|1.|(Medical Device) Sterility (Class<br>A, B, C, D)|||
|||||||2.|(Medical<br>Device)|Bacterial||
||||||||Endotoxin (Class A, B,|C, D)||
|||||situated at PLOT NO||||||
|||||82A SECTORR 5||||||
|||||HSIDC IMT||||||
|||||MANESAR||||||
|||37||M/s|M/s Edward food<br>research & analysis|TL/MD/2023/000010||1.<br>Gown (Sterility, BET)<br>2.<br>Surgical<br>Blades<br>(Sterility,|||
|||||centre|||BET)|||

. .

|||||3.<br>Eye Drap (Sterility, BET)||
|---|---|---|---|---|---|
|||||4.<br>Disposable<br>Syringe<br>(Single||
||situated at|||Use) (Sterility, BET)||
||SYNTHESIS|||5. Absorbent<br>Gauge<br>(Sterility,||
||BUSINESS PARK,|||BET)||
||CBD/1, UNIT-2-C/B,|||6.<br>Surgical<br>Needle<br>(Sterility,||
||2ND FLOOR, ACTION|||BET)||
||AREA II, RAJARHAT,|||7. Eye Pad (Sterility, BET)||
||NEWTOWN|||-||
|38||M/sMaeon|TL/MD/2023/000005|1.|Blood BagsWithout Blood||
||Lifescience||2.|Blood Transfusion Set||
||Laboratories Tamil||3.|Blood Vessels Stents||
||Nadu||4.|Catheters<br>(BET,<br>Bioburden,||
|||||Sterility)||
||||5.|Orthopedic<br>Device<br>-—<br>Bone||
||situated at No.14, 1st|||Prosthesis / Hip Prosthesis/Knee||
||Floor,<br>Lakshmikanthammal<br>First Street, Rajiv|||Prosthesis/Elbow<br>Prosthesis/Ortho<br>Locking<br>Plates/Bone<br>Plates/Bone||
||Nagar, Vanagaram|||Screws/Bone<br>Interlocking||
|||||Nails/Implants<br>(Sterility,<br>BET,||
|||||Bioburden)||
||||6.|Surgical Gloves (Bioburden)||
||||7.|Perfusion Set||
||||8.|Respiratory<br>Devices<br>-<br>Non||
|||||Sterile<br>Breathing||
|||||Circuits/Ventilator||
|||||Circuits/Disposable<br>Breathing||
|||||Bag (Bioburden)||
||||9.|Sterile Skin Stapler (Sterility)||
||||10.Sterile<br>Surgica!<br>Blades<br>(BET,|||
|||||Sterility)||
||||11.Sterile<br>Surgical<br>Sutures<br>(BET,|||
|||||Sterility)||
||||12.|SterileNeedles (BET, Sterility)||
||||13.Sterile<br>Surgical<br>Gloves<br>(BET,|||
|||||Sterility)||
||||14. <br>15.|SterileSurgical Needles<br> Sterile Syringe||
||||16.|Surgical Blades (Bioburden)||
||||17.Surgical<br>Gown<br>(Bioburden,|||
|||||Sterility)||
||||18.|Surgical Sutures (Bioburden)||
||||19.|Tubal Rings (BET, Sterility)<br>-||
||||20.Urological<br>Device<br>-<br>Stone|||
|||||Retrieval<br>Basket/Urethral||
|||||Dilator/Ureteral Access Sheath||
||||21.Catheters<br>(BET,<br>Bioburden,|||
|||||Sterility)||
||||22,Condoms<br>(Bioburden,|||
|||||Pathogens)|||

==> picture [12 x 9] intentionally omitted <==

----- Start of picture text ----- 29 ----- End of picture text -----

Copper T (BET, Sterility) 24. Hemodialysis Dialyser (Bioburden, Sterility)
Intra Ocular Lens

==> picture [502 x 658] intentionally omitted <==

----- Start of picture text -----

||||||||||
|---|---|---|---|---|---|---|---|---|
|26.|IV|Cannula/set|
|27.Medical|Device|Gauge|Bandage/|
|Cloth|(Bioburden,|Sterility)|
|28.|Medical|Device|Guide|Wire|
|29.|Medical|Device|Stent|
|30. Medical|Device|Stent|
|31.Medical|Device|Tube|
|Nasogastric|Tubes/Nephrostomy|
|Tube/|Jejunal|Feeding|
|Tube/Levin|Tube|
|32.Medical|Device|Valve|—|Luer|,|
|||Activated|Valves/Tuohy|
|||BorstAdapters|/Drain|
|Valves/Hemostasis|Valves|(BET,|
|Bioburden,|Sterility)|
|33.|Orthopedic|Device|-|Bone|
|||Prosthesis|/Hip|Prosthesis/Knee|
|Prosthesis/Elbow|
|||Prosthesis/Ortho|Locking|
|Plates/Bone|Plates/Bone|
|Screws/Bone|Interlocking|
|Nails/Implants|Orthopedic|
|Device|—|Bone|Prosthesis/Hip|
|Prosthesis/Knee|Prosthesis/|
|Elbow|Prosthesis/Ortho|Locking|
|Plates/Bone|Plates/Bone|
|||Screws/Bone|Inter-Locking|
|||||Nails/Implants|(Sterility,|BET,|
|Bioburden)|
|39|| Ws.|Trustin|TL/MD/2020/000002|1.|Nitrile|Gloves|(Class|B)|
|analytical|solutions|2.|Gynaecological|Gloves|
|private|limited|(Class|B)|
|||3.|Non|powdered|surgeons|
|situated|at|PLOT|NO-|glove|(Class|A)|
|303/B,|BLOCK-B,|RK|4.|Surgical|Gloves|(Class|B)|
|COMPLEX,|‘st|5.|Surgical/Examination|Gloves|
|FLOOR,|(Class|B)|
|THIRUNEERMALAI|6.|Non-latex|surgical|glove|
|ROAD,|PARVATHY|(Class|A)|
|PURAM,|7.|Non-latex|medical|
|CHROMPET,|examination|glove|(Class|A)|
|CHENNAI|8.|Latex|medical|examination|
|glove|(Class|A)|
|9.|Sterile|Examination|Gloves|
|Class|B|
|BS|
|30|

----- End of picture text -----

==> picture [177 x 108] intentionally omitted <==

----- Start of picture text ----- 10.Non-Sterile Surgical Gloves (Class A) 11.Non powdered surgeons glove (Class B) ~ ----- End of picture text -----

(Dr Rajeéy Sin aghuvanshi) Drugs Controller General (I)

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IT Cell for uploading the information on the CDSCO website.

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