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175 List of the Certified Medical Device Testing Laboratory under MDR, 2017 2022-Aug-17 5938 KB

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No. 29/Misc/03/2019-DC (211) Government of India Directorate General of Health Services Central Drugs Standard Control Organisation Medical Devices and Diagnostics9 Division ) 47 AUG 2022

Subject: List of the certified Medical Device Testing Laboratory (MDTL) under MDR, 2017- regarding

This office had registered a Medical Device Testing Laboratory (MDTL) to carry out test or evaluation of a medical device on behalf of the manufacturer (Form MD-40 of MDR, 2017). There are 18 MDTLs have been registered with CDSCO till dated 07.12.2021 under the provisions of the Medical Device Rules, 2017 (Form MD-40 enclosed). 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 is given below:

|||NAME & ADDRESS||
|---|---|---|---|
||SI.<br>No.|OF MEDICAL DEVICE|<br>TESTING|REGISTRATION<br>NO.<br>SCOPEOFTESTING|
|||LABORATORY||
||1|M/sSIPRA LABS|TL/MD/2019/000001| 1. Copper-T|
||||| LIMITED<br>| Address: 7-2-<br>| 1813/5/A, Adj. To Post<br>| Office, Industrial|2. Condoms<br>.<br>3. Sterile Hypodermic Needles<br>4. Tubal Rings<br>5. Hypodermic Syringes|
||||Estate, Sanathnagar,|6. Blood Bags|
||||Telangana,||
|||Hyderabad- 500018||
||<br>||2|M/s StarImaging&<br>Path Lab Pvt. Ltd.<br>Address: 4B/4, Tilak<br>Nagar<br>, West<br>Delhi,<br>Delhi (India) - 110018|TL/MD/2019/000002| 1. Bilirubin (Total and Direct) Test<br>Reagents / Kits<br>2.Creatinine testreagent/kit<br>3. AspartateAmino Transferase (AST /<br>SGOT) test<br>4. Alanine Amino Transferase|
||<br>|||||(ALT/SGPT) test<br>5. Uric Acid Test reagents / kits<br>6. Total Protein testreagents<br>/ kits<br>7. Activated partial thromboplastin time|
||<br>||||(APTT) test<br>8. PT (Prothrombin Time) Test reagents<br>/ Kits|
|||=.<br>| Research<br>Laboratories India||2. Sterilized Disposable Device<br>3.Sterilized Surgical Sutures|
|___,||Pvt.Ltd.||

|Address:<br>1652|MIE|||||
|---|---|---|---|---|---|
|Part<br>B,<br>Bahadurgarh,||||||
|Haryana — 124507||||||
|M/s SreeChitra<br>Tirunal Institute For<br>Medical Sciences&<br>Technology<br>Address: Medical<br>College,<br>Thiruvananthapuram,||TL/MD/2019/000004|1.Cardio Vascular Devices (Biological<br>Evaluation as per ISO 10993)<br>2.Neuroprosthesis (Biological<br>Evaluation as per ISO 10993)<br>3.Orthopedic Implants (Biological<br>Evaluation as perISO 10993)<br>4.All medical devices and Materials||||
|Kerala -695011|||||(Biological Evaluation as perISO|
||||||10993)|
|||||5.Dental|Dental Implants (Biological Evaluation|
||||||as per ISO 10993)|
|M/s,GLR<br>Laboratories Private<br>Limited<br>Address: GOKULAM<br>STREET, Mathur,<br>MATHUR, Chennai,<br>TamilNadu -600068||TL/MD/2019/000005|1. <br>2. <br>3. <br>4 <br>||||Cardiovascular devices (Biological<br>evaluation as per ISO 10993)<br> Orthopaedic devices (Biological<br>evaluation as per ISO 10993)<br> Oculardevices (Biological evaluation<br>as per ISO 10993)<br> Surgical devices andsutures<br>(Biological evaluation as per ISO|
||||||10993)|
|||||5.|Respiratory devices (Biological|
||||||evaluation as per ISO 10993)|
|||||6.|Gastrointestinal devices (Biological|
||||||evaluation as per ISO 10993)|
||||||7.|Urological devices (Biological|
||||||evaluation as per ISO 10993)|
|||||8.|Haematological devices and IV sets|
||||||(Biological evaluation as per ISO|
||||||10993)|
|||||9.|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)|
|||||12.|All medical devices and Materials|
||||||(Biological evaluation as per ISO|
|M/s,PALAMUR<br>BIOSCIENCES<br>PRIVATE LIMITED<br>Address: 401 Aikya,<br>4th Floor, H.No-10-3-<br>32/9/23, Opp.Faust<br>High School,East||TL/MD/2019/000006||1. <br>2. <br>3. <br>4.||10993)<br>a<br> Catheters (Biological Toxicity)<br> Disposable Hypodermic needles<br>(Biological Toxicity)<br> Surgical dressings (Biological<br>Toxicity)<br> Orthopaedic Implants (Biological<br>Toxicity)<br>oe|

|~|cy|||||<br>||||||Marredpally,<br>Secunderabad,<br>Hyderabad,<br>Telangana - 500026||5.<br>6. <br>7.|Blood Bags (Biological Toxicity)<br> Drug eluting stent(Biological<br>Toxicity)<br>Intra Ocular Lenses (Biological|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
||||||||||||||Toxicity)|
|||||||||||||8.|Sutures (Biological Toxicity)|
|||||||||||||9.|Condoms (Biological Toxicity)|
|||||||||||||10. Heart Valves (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||4.|Blood Bags|
|||||||||||Industrial Area,||5.|Catheters (Class D)|
|||||||||||Bengaluru<br>Pincode 560 058,||6. <br>7.|Catheters (Class B)<br>Catheters (Class C)|
|||||||||||INDIA, Bangalore,||8.|Heart valves|
|||||||||||Bengaluru<br>(Bangalore) Urban,||9.<br>Intra Ocular Lenses<br>10.1.V. Cannula||
||||||<br>|<br>|<br>|||||||Karnataka -560058||11. <br>12. <br>13.Peritoneal<br>**1**4**.**Condoms<br>15. <br>6|BoneCements<br> Internal Prosthetic Replacements<br>Peritoneal dialysis sets<br>Condoms<br> Intra-uterine devices<br> Surgical dressing|
|||||||||||||17.Scalp|Scalp Vein Set|
|||||||||||||18.|Ligatures and sutures|
|||||||8|||||M/s, TRUSTIN|TL/MD/2020/000002||1.|Disinfectant ( Sterility and|
|||||||||||ANALYTICAL|||Antimicrobial activities as per ISO|
|||||||||||SOLUTIONS|||11737-1 and 2, USP|
|||||||||||PRIVATE LIMITED|||42, EP 9.0, IP 2018, BP 2018)|
|||||||||||Address: Plot no-||2.|Catheters (Sterility, Bioburden and|
|||||||||||303/b, Block-B,|||BET as per ISO 11737-1 and 2, USP|
|||||||||||RK Complex, 1*|||42, EP 9.0, IP|
|||||||||||<br>|||Floor,Thiruneermalai<br>road, Parvathy puram,<br> Chrompet,<br>,||3.|2018,BP2018) -ClassA<br>Surgical Sutures (Physical<br>parameters, Sterility and BET as per|
|||||||||||Chennai,<br>Kanchipuram, Tamil|||ISO 11737-2, USP<br>42, EP 9.0, IP 2018, BP 2018) -|
|||||||||||Nadu - 600044|||Class B|
|||||||||||||4.|Surgical Dressings( Sterility<br>,|
||||||||||||||Bioburden, BET as per IS 758, IS|
||||||||||<br>|||||||1954, ISO 11737-1and 2, IP 2018,<br>USP 42, BP 2018 and EN9.0) -<br>ClassA|

|5.|Surgical Dressings( Sterility ,<br>Bioburden, BET as per IS 758, IS<br>1954,ISO11737-1and 2, IP2018,<br>USP 42, BP 2018 and EN9Q.0) -||<br>|<br>|||
|---|---|---|---|
||Class B|||
|6.|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 C|||
|7.|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) -|||
||Class D|||
|8.|Blood bags with and without|||
||anticoagulant solutions (Mechanical,|||
||Sterility and BET as per ISO 3826,|||
||IS 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|||
||ISO4074-2015, WHOUNAIDS2010,<br>1SO25841-2017,||||
||WHOUNAIDS2012,Schedule R,|||
||1$011737-1, IP 2018, USP42|||
|10.Catheters (Sterility, Bioburden and||||
||BET as per ISO 11737-1 and 2, USP|||
||42, EP 9.0, IP|||
||2018, BP 2018) - Class B|||
|11.Catheters|Catheters (Sterility, Bioburden and|||
||BET as per ISO 11737-1 and 2, USP|||
||42, EP ¢.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, 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|||
|15.IntraocularLenses(Sterility,||||

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----- Start of picture text ----- | | 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 18. Cardiac Stents ( Sterility test as per 1S$O011737-2, 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 testing, Sterility, Bioburden and BET | | 25. Disposable Perfusion sets (Physical 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 | 26. Intraocular Lenses (Sterility, | Bioburden, BET and Pathogen | identification as per ISO 11737 - Part1 and 2, USP 42, EP9.0, ----- End of picture text -----

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|||IP 2018, BP 2018)<br>27.\nternal Prosthetic Replacements|IP 2018, BP 2018)<br>27.\nternal Prosthetic Replacements|||
|---|---|---|---|---|
||||(Sterility test as per ISO 11737-2,||
||||USP 42,||
||||EP 9.0, IP 2018, BP 2018)||
|||28.|Heart Valves (Sterility test as per||
||||ISO-11737-2, USP 42, EP 9.0, IP||
||||2018, BP 2018)||
|||29.Surgical|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 |S 13009-2000, ISO||
||||11737-2, USP 42, EP 9.0, IP2018,||
||||BP 2018)||
|||32.|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<br>, BP 2018)||
|||35.|Disposable Hypodermic Syringes||
||||(Sterility and BET as per ISO 11737-||
||||2, USP 42, EP9.0, IP 2018, BP||
||||2018)||
|M/s, Devansh|TL/MD/2020/000003||1.|Catheters — Class A||
|Testing & Research||2.|Catheters (Excluding Bio-||
|Laboratory Pvt. Ltd.|||compatibility testing) - Class B||
|Address: RZ-21A/331,||3.|Catheters (Excluding Bio-||
|Madanpuri, Gali No.-|||compatibility testing)- Class C||
|10, West Sagar Pur,||4.|Disposable Perfusion Sets||
|Delhi, West Delhi,|||(Excluding Biocompatibility testing) -||
|Delhi - 110046|||Class C||
|||5.|Disposable Hypodermic Needles||
||||(Excluding Bio-compatibility testing)||
||||- Class C||
|||6.|DisposableHypodermicNeedles__||

| | | { | | | | | | | ; | | | | | | | | | |

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(Excluding Bio-compatibility testing) - Class D
1. Disposable Hypodermic Syringes - Class A
1. Disposable Hypodermic Syringes (Excluding Bio-compatibility testing) - Class B
1. Disposable Hypodermic Syringes (Excluding Bio-compatibility testing) - Class C
1. Disposable Hypodermic Syringes (Excluding Bio-compatibility testing) - Class D

I.V. Cannulae - Class A 12. I.V. Cannulae (Excluding Biocompatibility testing) - Class B
|.V. Cannulae (Excluding Biocompatibility testing) - Class C
I.V. Cannulae (Excluding Biocompatibility testing) - Class D
Scalp Vein Set - Class A 16. Scalp VeinBiocompatibility Set (Excludingtesting) - Class B 17. Scalp Vein Set (Excluding Biocompatibility testing) - Class C
Scalp Vein Set (Excluding Biocompatibility testing) - Class D
Surgical Dressings - Class A 0. Surgical Dressings (Excluding Biocompatibility testing) - Class B
Surgical Dressings (Excluding Biocompatibility testing) - Class C
Surgical Dressings (Excluding Biocompatibility testing) - Class D
Contraceptives - Class A
Contraceptives (Excluding Biocompatibility testing) - Class B
Contraceptives (Excluding Biocompatibility testing) - Class C
Contraceptives (Excluding Biocompatibility testing) - Class D
Disinfectant - Class A
Catheters (Excluding Biocompatibility testing) - Class D
ClassDisposableA Hypodermic Needles -
Disposable Hypodermic Needles (Excluding Bio-compatibility testing) - Class B
Disinfectant (Excluding Biocompatibility testing) - Class B

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|||32.|Disinfectant (Excluding Bio-<br>compatibility testing) - Class C||<br>|||<br>||
|---|---|---|---|---|---|
|||33.|Disinfectant (Excluding Bio-|||
|||34.|compatibility testing) - Class D<br> Disposable Perfusion Sets - ClassA|||
|||35.|Disposable Perfusion Sets<br>(Excluding Biocompatibility testing)|-|||
||||Class B|||
|||36.|Disposable Perfusion Sets<br>(Excluding Biocompatibility testing)|||
|M/s,JAGDAMBA<br>LABORATORIES<br>Address: 119,<br>Solitaire Industrial<br>Park, Phase-1,<br>Dahmikallan, Bagru,<br>Jaipur, Rajasthan-<br>303007|TL/MD/2020/000004||1. <br>_ <br>3. <br>4. <br>5.|Catheters (Testas per ISASO 10555)<br>- ClassA<br> Disinfectants (As per IP, BP, USP)-<br>Class B<br> Disposable Hypodermic Needles<br>(Testas per IS 10654) - Class B<br> Disposable Perfusion Sets (Testas<br>per IS 12655) - ClassA<br> Disposable Perfusion Sets (Test as||||
|||6.|per IS 12655) - Class B<br> Catheters (Test as per IS/ISO 10555)|||
||||- Class B|||
|||7.||.V. Cannulae (Test as per IS/ISO|||
||||10555) - Class B|||
|||8. <br>9.|Disposable Hypodermic Syringes<br>(Testas per 1S10258) - Class B<br> Scalp vein set (Test as per IS 16097)|||
||||- Class B|||
|||10. Surgical Dressings (Cotton and||||
||||Gauze, Bandage)-Class B|||
|||11. Surgical Dressings (Cotton and||||
||||Gauze, Bandage)-Class A|||
|ITLLABSPVTLTD<br>B-283-284,<br>MangolpuriIndustrial<br>Area, Phase |, North<br>West Delhi,<br>Delhi - 110083|TL/MD/2021/000001|11.<br>Catheters (Excluding Bio-<br>|<br>compatibility testing) Class D<br>2. SurgicalDressings (Excluding<br>|<br>Biocompatibility testing) Class D<br>|<br>3.<br>Disposable Hypodermic Syringes<br>Class D<br>4.<br>Disposable Hypodermic Syringes<br>(Excluding Bio-compatibility testing)||||
||||Class D|||
|||_<br>Surgical Dressings Class D<br>6.<br>Disposable Hypodermic Needles<br>(Excluding Bio-compatibility testing)||||
||||Class C|||
|||7.<br>Contraceptives Class D||||
|||8.<br>1|.V. Cannulae (Excluding Bio-||||
||||compatibility testing) Class C|||
|||9.<br>SurgicalDressings(Excluding||||

||||||Biocompatibility testing) Class D|
|---|---|---|---|---|---|
|°||||10.|Scalp Vein Set (Excluding|
||(||||Biocompatibility testing) Class B|
|||||11.|Disposable Hypodermic Needles|
||||||Class C|
||||<br>||||12. <br>13.||.V.CannulaeClassC<br> |.V. Cannulae (Excluding Bio-<br>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|
|||||18.|Disposable Perfusion Sets|
||||||(Excluding Biocompatibility|
||||||testing) Class C|
|||||19.|Disinfectant (Excluding Bio-|
||||||compatibility testing) Class B|
|||||0.|Disposable Perfusion Sets ClassC|
|||||21.|Disposable Perfusion Sets|
||||||(Excluding Biocompatibility|
||||<br>|||2.|testing) ClassC<br> Disposable Hypodermic Needles|
||||||(Excluding Bio-compatibility testing)|
||||||Class D|
|||||23.|Surgical Suture Class D|
|||||24.|Urine collecting bag Class B|
|||||25.|Surgical Gloves ( Sterile/Non Sterile)|
||||||Class D|
||||<br>|||6. <br>27.|Endotracheal (ET) tube ClassB<br> 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<br>Labs Private Limited||1.|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; Class C<br> Copper T; ClassC<br> Sutures; Class C<br>Disposable Hypodermic needles;|
||||Gujarat - 382213|6.|Class C<br>Catheters; Class D|
||||||7.|Disposable Hypodermic Syringes;|
||||||Class B|
|||||8.|Blood bags; Class B|
|||||9.|Condoms; Class C|
|||||10.|Coronary stents; Class D|
||||9|||

|||||41.IntraOcularLenses Implants; Class<br>D||<br>||||
|---|---|---|---|---|---|---|---|
|||||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 <br>14||M/s,<br> |Brothers|M/s, Conformity<br>Testing Labs Pvt Ltd<br>WH-52, Mayapuri<br>Industrial Area, Phase<br>1, New Delhi, West<br>Delhi, Delhi - 110064<br>Brothers<br>Laboratories Pvt. Ltd<br>103, D-3, Industrial<br>Area Jhotwara, Jaipur,<br>Rajasthan -302012|TL/MD/2021/000003|1.NIBP; Class B<br>2.IBP; ClassC<br>3.Nebulizer; Class C<br>4.Thermometer; Class B<br>|<br>5.Glucometer; Class B<br>|<br>|<br>TL/MD/2021/000004|1.DisposableHypodermic Needles; ——]<br>Class B<br>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||||
|||||8.1V Canulae; Class B||||
|||||9.Scalp Vein Set; Class B||||
|||M/s, Shiva<br>Analyticals (India)<br>Private Limited<br>situated at Plot Nos.<br>24D (P) & 34D,<br>KIADB Industrial<br>Area, Hoskote,<br>Bangalore, Hoskote,<br>Bengaluru<br>(Bangalore) Rural,<br>Karnataka - 562114|TL/MD/2021/000005||1. Cardiac Stents (Test- Ethylene<br>Oxide residue,<br>Standard/Specification-ISO<br>10993-7-2008) Class C, Class D<br>2. Catheters (Test- Ethylene Oxide<br>residue, Standard/Specification-ISO<br>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<br>4.<br>Drug Eluting Stents (Test- Ethylene|||||
|||||Oxide residue,||||
|||||Standard/Specification-ISO-10993-||||
|||||7-2008) Class D||||
|||||5.<br>Heart Valves (Test- Ethylene Oxide||||
|||||residue, Standard/Specification-ISO||||
|||||10993-7-2008) Class D||||
|||||16.<br>Intra Ocular Lenses (Test- Ethylene||||
|||||Oxide residue,||||
|||||Standard/Specification-ISO 10993-7-||||
|||||2008) Class C||||
|||||7.<br>IV Cannula (Test- Ethylene Oxide||||
|||||residue,Standard/Specification-ISO||||

| | 10993-7-2008) Class B, Class C
“a | | 8. Orthopaedic Implants (TestStandard/Specification-ISO 10993-7-
| Ethylene Oxide residue, || || 9. Scalp2008) VeinClassSetB, (Test-Class EthyleneC, Class D. Oxide residue, standard/Specification-ISO10993-72008) Class B
1. Surgical Dressings (Test- Ethylene Oxide residue, tandard/Specification-ISO 10993-72008) Class A, Class B, Class C, Class D
| 11. Disposable Hypodermic Needles (Test-Ethylene Oxide residue, Standard/Specification-ISO 10993-72008) Class B
1. Disposable Hypodermic Syringes
| | 2008)Standard/Specific(Test-EthyleneClass B, Cl a Oxidesstion-ISOC residue, 10993-713. Ablation Device (Test- Ethylene Oxide residue, Standard/Specification-ISO-109937-2008
16 | M/s, APEX QUALITY] TL/MD/2021/000006 |1. Infusion/Syringe Pump ( Flow Rate, CERTIFICATION Volume, Occlusion Pressure, SERVICES PVT. LTD. Electrical Safety) (Reference situated at 161, Standard IEC 60601-2-24, KASTURBA NAGAR, 1S13450(Part2 Sec24)and IEC NIRMAN NAGAR, 60601-1). Class C. Jaipur, Jaipur, 2. Aspirator( Vacuum Testing,
|| | Rajasthan - 302019 60601-1)StandardElectrical —Safety)ISOClass10079-1(ReferenceC. and IEC 3. Glucometer (Glucose Concentration Testing) (Reference Standard ISASO 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) (Reference

||Standard 1SO27427.2013 and IEC|Standard 1SO27427.2013 and IEC|||
|---|---|---|---|---|
|||60601-1) Class C.|||
||6.|Digital Thermometer, (Temperature|||
|||Testing) (Reference Standard -|||
|||IS/ISO|||
||80601-2-56. 2017 and IS 3055 Part 1||||
||and Part 2 and IS 6274||||
|M/s, Shri Ram<br>Scientific And<br>Industrial Research<br>:<br>eee|TL/MD/2021/000007 | 1.|Tubal Rings/Fallopian Rings<br>(Shape, Dimensions, Fracture<br>Test, Memory Test, Friction Force<br>Test, Fatigue Test, Radio Opacity,<br>Sterility, Identification of polymer)|||
|Address: 8E, Diamond<br>Press Building,<br>Jhandewalan<br>Extension. Rani<br>Jhansi Road, Delhi,<br>New Delhi, Delhi -<br>110055|2.<br>3.|Male LatexCondoms (Dimensions,<br>Burstvolumeand pressure test,<br>WaterLeakage test, Quantity of<br>lubricant, ColourFastness, Integrity<br>ofindividual package seal,<br>Labeling packaging and storage)<br> COPPER-T380A (Physical<br>Parameters and Dimensions,|||
|||Pouch burst strength, Amt of|||
|||copper wire, Strength of the Tie,|||
|||Copper collar pull force, Sterility)|||
||4.||Implantable Medical Devices|||
||||(Physical Parametersand<br>Dimensions, Sterility Test, BET||<br>|<br>|||
||||Test, Bio-Burden Test)|||
||5.|Implantable Medical Devices|||
|||(Physical Parameters and|||
|||Dimensions, Sterility Test, BET|||
|||Test, Bio-Burden Test)|||
||6.|IUCD-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<br>lumen, Sterility, Bacterial||||
|||Endotoxin)|||
||8.|Disposable syringe (Extraneous|||
|||matter, Acidity or Alkalinity,|||
|||Extractable Metals Lubricant,|||
|||Physical Parameters and|||
|||Dimensions, Sterility Test, Bacterial|||
|||Endotoxin)|||

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Disposable syringe (Extraneous matter, Acidity or Alkalinity, Extractable Metals Lubricant, Physical Parameters and Dimensions, Sterility Test, Bacterial

| Endotoxin) 10. Surgical dressings (Threads, weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)

Surgical dressings (Threads, weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)
Surgical dressings (Threads, weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)

| 13. Sterile Hypodermic Syringe for | Single use (Sterility Test, Bacterial Endotoxin Test)

Cardiac Stent (Sterility Test) 15. Cardiac Stent (Sterility Test) 16. Catheters (Dimensions, Sterility Test)
Catheters (Dimensions, Sterility Test)
Blood Bags (Sterility Test, BET, Chemical Analysis, Physical Dimensions)
Blood Bags (Sterility Test, BET, Chemical Analysis, Physical

| || 20. DisposableDimensions)Hypodermic Needles | (Acidity or Alkalinity, Extractable | Metals, Physical Parameters and Dimensions, Performance Bond - Hub and Needle tube, Patency of lumen, Sterility, Bacterial Endotoxin)

Surgical dressings (Threads,

| weight, Length and width, foreign matter, fluorescence, packaging, labelling and storage)

Umbilical Tapes (Physical Test, Adhesive, Strength, Length dia)
Umbilical Tapes (Physical Test, Adhesive, Strength, Length dia)

| 24. IV Cannula (Dimensions, Sterility) | 25. IV Cannula (Dimensions, Sterility) | 26. Copper-T (Sterility Test, Membrane

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||||||Filtration Method)||||
|---|---|---|---|---|---|---|---|---|
|||||27.|Suture absorbable / Suture non-|||||
||||||absorbable Synthetic (Sterility Test,|||||
||||||Direct Inoculation Method)||||
|||||28.|Tubal Ring (Sterility Test,||||
||||||Membrane Filtration Method||||
|18.||Mis,VIVO BIOTECH |TL/MD/2021/000008 <br>LTD<br>Address: 3 Floor, Ilyas<br>Mohammed Khan||||1. <br>2.<br>3. <br>4.|Infusion Set Class B<br>Sutures Class<br> Transcatheter Aortic Valve Class D<br> Tubal Ring Class C||||
||Estate, D. No. 8-2-<br>672/ 5& 6, Road<br>No.1, Banjara Hills,<br>Hyderabad,|||5. <br>6. <br>7.<br>8.|Blood Collection Sets Class D<br> Blood Bags Class<br>Intraocular Lens ClassC<br> Orthopedic Implants Class||||
||Hyderabad,||||||||
||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||||
|20|Mayapuri Industrial<br>Area, Phase 1, New<br>Delhi, West Delhi,<br>Delhi - 110064<br> |Ms, OasisTest<br>House Limited<br>situated atSP-2,22<br>Godam Industrial<br>Estate, Jaipur-<br>302006.<br>, Jaipur,<br>Jaipur, Rajasthan -<br>302006|TL/MD/2022/000001|| <br>||4. <br>5. <br>6. <br>7.<br> 1. <br>2.<br> 3. <br>4. <br>5. <br>6. <br>7. <br>8.|Bone Marrow cell separator<br> PET Equipment<br> X-Ray Equipment<br>DialysisMachine<br> Orthopaedic Implants<br>Intraocular lens<br> CatheterclassA<br> Bone cement<br> Bloodbags<br> Catheter Class B<br> Disposable Hypodermic Needles<br>Disposable Perfusion Sets|||<br>|<br>|<br>|<br>|||
|||||9.<br>Disposable Hypodermic Syringes|||||
|||||10. IV Cannulae|||||
|||||11.Scalp Ven Set|||||
|||||12.surgical dressings|||||
|||||13.Sutures and Ligatures|||||
|||||14. Intrauterine Device|||||
|21||M/s, Oasis Test<br>House situated at24|TL/MD/2022/000003|||1. Catheters - ClassA<br>2.<br>Intra Ocular Lenses - Class C||||
||A-B, Sardar Patel<br>Industrial Estate,|||3. Orthopedic Implants -Class C<br>4.<br>Surgical Dressings - Class B||||||
||Narol, Anmedabad,<br>Gujarat<br>- 382405||||5. Orthopedic Implants - Class D<br>6. Scalp vein set - Class B<br>7.<br>Disinfectants - Class B||||
||||||8.<br>Infusion sets - Class B||||
||||||9.<br>Blood bags - Class C||||
||||||10. Catheters - Class B||||
||||||11. Disp Hypodermic Needles-Class||||
||||||B||||
||||||12.DisposablePerfusionSets-Class||||

|||||||||||13.|B<br> Disp Hypodermic Syringes-Class|
|---|---|---|---|---|---|---|---|---|---|---|
|o|||||||||||B|
||||||||||14.|Disposable Perfusion Sets- class|
|||||||||||A|
||||||||||15.IV Cannulae - Class B||
|||||||>)|||MlsAstute Labs Pvt. <br>Ltd..,||TL/MD/2022/000004 | 1.<br>2.|X-ray Equipment for Radiography<br>and Radioscopy—ClassC<br>Cardiac Defibrillators-Class C|
|||||||||||Sr. No. 82/1, Bajirao<br> Dhawade Patil<br>Industrial Estate, NDA<br>Road, Shivane, Pune,<br>Maharashtra -411023|3.<br>4.<br>5.|Invasive<br>Blood<br>Pressure<br>Monitoring Equipment -ClassC<br>Mammographic X-ray Equipment<br>and Mammographic Stereotactic<br>Devices - ClassC<br>Peritoneal<br>Dialysis<br>Equipment<br>-|
|||||||||||Class C|
||||||||||6.|Ultrasonic Medical Diagnostic and|
|||||||||<br>|||7.|Monitoring Equipment - Class B<br>X-ray Equipment for Interventional|
|||||||||||Procedures - Class C|
||||||||93||M/sINSTITUTEFOR<br>INDUSTRIAL<br>RESEARCH &<br>TOXICOLOGY<br>£209<br>PHASE 1,UPSIDC,||TL/MD/2022/000005 | 1.<br>2.|Foley Catheter Two way (Test<br>Parameter BET and<br>Sterility)<br>-<br>Class D<br>DISPOSABLE<br>ELECTRODE<br>RECORDING CATHETER (Test<br>Parameter-BET and<br>Sterility)<br>-<br>Class D|
||||||<br>||||||M.G. ROAD,<br>Ghaziabad, Uttar<br>Pradesh, 201001<br>Ghaziabad (India) -<br>245101|3.<br>4.<br>5.|INTRODUCER<br>SHEATH<br>CATHETER (Test Parameter-BET<br>and Sterility)<br>-Class D<br>DOUBLE<br>LUMEN<br>CATHETER<br>SET<br>(Test Parameter-BET and<br>Sterility)<br>- Class D<br>DISPOSABLE<br>CENTRAL|
|||||||||||VENOUS<br>CATHETER_<br>(Test<br>Parameter-BET<br>and<br>Sterility)<br>-|
|||||||||||Class D|
||||||||||6.|DOLPHIN<br>SUTURES<br>(Test|
||||||||||7.|parameter Sterility)<br>- ClassC<br>DISPOSABLE<br>EMBOLECTOMY|
||||||||||<br>|||CATHETER (Test Parameter-BET<br>and Sterility)<br>- Class D|
||||||||||8.|DISPOSABLE|
|||||||||||THERMODILUTION<br>CATHETER|
|||||||||||(Test<br>Parameter-BET<br>and|
|||||||<br>|||||<br>|<br>||9.<br>10.|Sterility) - Class D<br>Foley Catheter Two way<br>(Test<br>Parameter BET and Sterility)<br>-<br>Class B<br>Male Catheter (Test Parameter-|
||||||||||||BET and Sterility)<br>- Class B|
||||||||||15||

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|||||||11.|Ryles<br>Tube<br>14FG<br>(Test|<br>Parameter-BET,<br>Bioburdan<br>and||Ryles<br>Tube<br>14FG<br>(Test|<br>Parameter-BET,<br>Bioburdan<br>and||
|---|---|---|---|---|---|---|---|---|
||||||||Sterility)<br>- Class B||
|||||||12.|Endotracheal<br>tube<br>(Test||
||||||||Parameter-BET,<br>Bioburdan<br>and||
||||||||Sterility) - Class B||
|||||||13.|Coronary<br>Artery<br>Cannula<br>(Test||
||||||||Parameter-BET<br>and<br>Sterility)<br>-||
||||||||Class B|||
|||||||14.|Natural rubber latex condom (Test||
||||||||Parameter-BET ) - Class B||
|||||||15.|Urethreal<br>Catheter<br>(Test||
||||||||Parameter-BET<br>and<br>Sterility)<br>-||
||||||||ClassD||
|||||||16.|Multiple<br>Lumen<br>Catheter<br>(Test||
||||||||Parameter-BET<br>and<br>Sterility)<br>-||
||||||||ClassB||
|24|||Mls Vorick Analytical <br>Research Pvt. Ltd.||||TL/MD/2022/000006|1.|Lint Bandage<br>- Dimensions, pH<br>Value,<br>Scouring<br>Loss,<br>Freedom||
||||||||from optical Witness ClassA||
|||Plot No. 252, Sector—<br>K, Bhorgarh Industrial||||2.|Heart Valves - Heavy toxic metals<br>as<br>Arsenic,<br>lead,<br>Cadmium,||
|||Area, Bawana-<br>Il,<br>Narela, North Delhi,<br>Delhi (India)<br>- 110040||||3.|Mercury<br>Particulate<br>Contamination, Sterility Class<br>D<br>|<br> Disposable<br>Perfusion — set<br>-|<br>|||
||||||||Particulate contamination, Tubing<br>length, Flow rate, Heavy Metals,|||
||||||||Acidity<br>or<br>alkalinity,<br>Residue on||
||||||||evaporation,<br>UV<br>absorption<br>of||
||||||||extract solution, Sterility Class B||
|||||||4.|Heavy<br>toxic<br>metals<br>as<br>Arsenic,||
||||||||lead,<br>Cadmium,<br>Mercury,||
||||||||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.|Contamination, Sterility Class C<br>Ablation<br>Devices-<br>Heavy<br>toxic<br>metals<br>as<br>Arsenic,<br>lead,|<br>Cadmium,<br>Mercury,<br>Particulate|||
||||||||Contamination, Sterility Class D||
|||||||7.|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||

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| |

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----- Start of picture text ----- substances, Sterility Class B 9. Bone Cements-Heavy toxic metals as Arsenic, lead, Cadmium, Mercury, Sterility Class Cc 10. Contraceptives- Heavy _ toxic metals as Arsenic, lead, Cadmium, Mercury, | Water Leakage test, Bursting volume and pressure test, dimension, Sterility Class C 41. 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, Needle hub, tube, point, Sheath, Performance, Sterility Class C 19. Internal Prosthesis - Heavy toxic Cadmium,metals asMercuryArsenic,Particulatelead, 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 ----- End of picture text -----

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||gm/m2,<br>Scouring<br>loss/Foreign||
|---|---|---|
||matter,<br>Absorbency,<br>Freedom||
||from optical Whitness, pH value of|||
||aqueous extract, Sterility Class A|||
|22.|Orthopedic Implants- Heavy toxic||
||metals<br>as<br>Arsenic,<br>lead,<br>Cadmium,<br>Mercury,<br>Particulate||
||Contamination, Sterility Class D||
|23.|Surgical<br>Dressing<br>IHS/ As_ per<br>manufacturer specifications Class||
||D||
|24.|Internal Prosthesis<br>- Heavy toxic||
||metals<br>as<br>Arsenic,<br>lead,<br>Cadmium,<br>Mercury<br>Particulate |||
||Contamination, Sterility Class C||
|25.|Disposable<br>Perfusion — set<br>|<br>Particulate contamination, Tubing<br>length, Flow rate, Heavy Metals,<br>|<br>Acidity<br>or<br>alkalinity,<br>Residue on||
||evaporation,<br>UV<br>absorption<br>of||
||extract solution, Sterility ClassA||
|26.|Surgical<br>Dressing<br>-<br>Bleached |<br>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<br>C|||
|27.|IV Cannula<br>- Limits for acidity or||
||alkalinity,<br>Intravascular<br>Catheter,||
||Distal end, Hub, Effective length,||
||Outside Diameter, Corrosion Test,||
||Peak tensile force, Freedom from||
|28.|leakage, Sterility Class B<br>Crepe Bandages<br>- Dimensions,|<br>Weight<br>per<br>unit<br>area,<br>Stretchability,<br>breaking<br>load,<br>|<br>Chemical Neutrality. Class A<br>|||
|29.|POP Bandages<br>-<br>Setting<br>Time,||
||Tensile<br>Strength,<br>Coane||
||strength Class A||
|30.|Disposable<br>Perfusion<br>set<br>-||
||Particulate contamination, Tubing||
||length, Flow rate, Heavy Metals,||
||Acidity or<br>alkalinity,<br>Residue on||
||evaporation,<br>UV<br>absorption<br>of||
||extract solution, Sterility Class C||
|31.|Catheters-<br>Length,<br>Diameter,||
||Heavy<br>toxic<br>metals<br>as Arsenic,||
||lead,<br>Cadmium,<br>Mercury,||
||Particulate Contamination, Sterility||
||ClassA<br>|||

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----- Start of picture text ----- 32. Catheters- Length, Diameter, . | Heavy toxic metals as Arsenic, ( lead, Cadmium, Mercury, Particulate Contamination, Sterility Class B 33. Catheters- Length, Diameter, | Heavy toxic metals as Arsenic, | lead, Cadmium, Mercury, | Particulate Contamination, Sterility Class C 34. Catheters- Length, Diameter, Heavy toxic metals as Arsenic, lead, Cadmium, Mercury, Particulate Contamination, Sterility Class D 35. Orthopedic Implants- Heavy toxic | metalsCadmium, asMercury,Arsenic,Particulatelead, Contamination, Sterility Class C 36. Surgical Dressing - Bleached Gauze, Length, Width, Weight in | || gm/m2,matter, Absorbency,Scouring loss/ForeignFreedom | | from optical Whitness, pH value of | aqueous extract, Sterility Class B | 37. Disposable Hypodermic Syringe - Capacity, Fiducial Line, Limits for acidity or alkalinity, Metal, Lubricant, Scale, Barrel, Piston, | Nozzle, Performance, Reducing | substances, Sterility Class B 38. Rolled Bandage - Dimensions, pH Value, Scouring Loss, Freedom from optical Witness Class A Vea (Dr V G Somani) Drugs Controller General (I) ----- End of picture text -----

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