Statement Indicating Status on Grant of Approval by CLAA for Manufacture of Notified Medical Devices. (Jan to December 2010)

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1 Statement Indicating Status on Grant of Approval by CLAA for Manufacture of Notified Medical Devices (Jan to December 2010) # Name of the Manufacturer Product Licenced by CLAA Manufacturing Licence No. & Validity 1. M/s. Dispo Medical Devices Private Limited 2. M/s. Spectra Vision, Plot No. 14, Shed no. 44, 45 & 46, B/H. S.T. Workshop, Near Maruti Service Centre, GIDC, Chitra, Bhavnagar, Dist-Bhavnagar M/s. M.J. Surgical, Ahmedabad 1. Intravenous Catheter 2. Catheters 3. Scalp Vein Sets 1. Single piece PMMA Intra Ocular Lens (SPECTRAPMMA) 2. Single piece PMMA Intra Ocular Lens (i-lens) 3. Single piece PMMA Intra Ocular Lens (SOFLENS) 1. Bone Screws (S.S.) 2. Bone Screws (Titanium) 3. Bone Plates (S.S.) 4. Bone Plates (Titanium) 5. Complete Hip joint Systems 6. Nails (S.S.) 7. Nails (Titanium) 8. Pins (S.S.) 9. Pins (Titanium) 10. Wires (S.S.) 11. Wires (Titanium) 12. Spinal Implants (S.S.) 13. Spinal Implants (Titanium) G/28/1320 (Nov to Nov 2014) G/28/1320 (Nov to Nov 2014) G/28/1316 (Oct to Sep. 2014)

2 4. M/s. Polymer Technologies International (EOU), Block No. 310/C, Village-Dabhasa Tal-Padra, Dist-Vadodara M/s. Lifeline Systems Private Limited, A-49, Sector-8, Noida, Gautam Budh Nagar (U.P.) 6. M/s. N.S. Remedies private Limited, Shilpangan-2 nd Floor, (CFB), L.B.-1, Sector-III, Kolkata M/s. Mishra Dhatu Nigam Limited, (Govt. of India Enterprises) Ministry of Defence, P.O. kanchanbagh, Hyderabad M/s. Bombay Ortho Industries, Plot No. 551/G, Lodhika Village, Matoda G.I.D.C., P.O. Matoda, Dist- Rajkot 9. M/s. Care Group India, Block No. 310/E, Village Sim Ka Dabhasa, tal. Padra, Dist- Vadodara Single piece PMMA Intra Ocular Lens (Sterile) (EYE-O-CARE) 2. Foldable Hydrophilic Acrylic Intra Ocular Lens (Sterile) (Ultima) 3. Foldable Hydrophilic Yellow Acrylic Intra Ocular Lens (Sterile) (Gold) 4. Foldabale Hydrophobic Intra Ocular Lens (Sterile) (Acriol) 5. Endo Capsular Ring PMMA (Sterile) (Endo capsular Rings) 1. I.V. Cannula 2. Sterile catheters for I.V.use 3. Suction Catheters 4. Foley Catheters 5. Catheter-Peritoneal Dialysis 1. Zillion (Cobalt Chromium coronary stent system, L-605) 2. Lysis (Stainless Steel Coronary stent System, 316L) 1. Fracture Care Device 2. Intra Medullary Nails 3. Spinal Products 4. External Fixators 5. Prosthesis 6. Maxillo-facial 1. Bone Screws 2. Bone Plates 3. Nails 4. Pins/Wires 5. Joint replacement prosthesis 6. Spinal Implants 1. Single Piece PMMA Intraocular Lens 2. Single Piece PMMA Yellow Intraocular lens 3. Foldable Hydrophilic Acrylic Intraocular Lens 4. Foldable Hydrophilic yellow Acrylic Intraocular Lens 5. Endo Capsular Ring PMMA 6. Foldable Hydrophilic Acrylic G/28/1321 (Dec to Dec. 2014) 08/SC/PO/2008 (Nov to Nov. 2013) DL-824-MB (Sep to Sep. 2014) 52/RR/AP/2009/MD/G (Dec to Dec. 2014) G/28/1322 (Jan to Jan. 2015) G/28/1333 (May to May. 2015)

3 10. M/s. Sky Surgicals, Plot No. G-1950/2, Almighty Gate, GIDC Lodhika, Metoda Distt- Rajkot (Guj) 11. M/s. Alpha Therapeutics Private Limited, Survey No. 869/1, Village Rajora, Near Karnavati Hotel, Sarkhej- Bavla Highway, Tal-Balva, Distt-Ahmedabad M/s. TTK Healthcare Limited (Ortho Division) Nop. 290, SIDCO Industrial Estate, Anbattur, Chennai M/s. MRK Healthcare, S. No. 153/P, Panch Pipal, Village Hansapur, Unjha-Patan road, Tal-Patan, Distt-Patan Bone Screews 2. Bone Plate 3. Nail for Tibia/Humerous/Femur/Suppracondular 4. Hiop Fixitaon Implants 5. Spine Implants 6. Arthroscopy Implants 7. Locking Systems 8. Maxillofacial Implants 9. Wire & Pins 1. Sterile Disposable Single use Scalp Vein Set 2. Catheter Sterile Disposable Single use Ryle s Tube 3. Catheter Sterile Disposable Single use Feeding Tube 4. Catheter Sterile Disposable Single use Suction Catheter 5. Catheter Sterile Disposable Single use Urethral Catheter 6. Catheter Sterile Disposable Single use Abdominal Drainage Kit 7. Catheter Sterile Disposable Single use Chest Drainage catheter 8. Catheter Sterile Disposable Single use Nelaton Catheter 9. Catheter Sterile Disposable Single use Foley s Catheter 10. Catheter Sterile Disposable Single use Nasal Oxygen Catheter 11. Catheter Sterile Disposable Single use Stomach Tube 1. Total Condylar Knee System 2. Total Hip System 3. Plates 4. Screws 5. Conventional Implants 1. Latex Foley Balloon Catheters 2 Way, (Silicon treated) 2. Latex Foley Balloon Catheters 3Way, (Silicon treated) 3. Latex Catheter without Balloon (Silicone treated) 4. Latex Foley Balloon Catheters 2Way 5. Latex Foley Balloon Catheters 3Way 6. Latex Catheter without Balloon G/28/1342 (July 2010 to July 2015) G/28/134 (July 2010 to June 2015) TN /2008 (July 2009 to July 2014) G/28/1343 (July 2010 to July 2015)

4 14. M/s. Umacure Medical Devices Private Limited, Plot No. 4002, Phase-IV, GIDC, Vatva, Ahmedabad 1. Sterile Scalp Vein Set 2. Sterile Ryle s Tube 3. Sterile Stomach Tube 4. Sterile Levin s Tube 5. Sterile Nasogastric Tube 6. Sterile Duodenal Tube 7. Sterile Infant Feeding Tube 8. Sterile Infant Mucus Extractor 9. Sterile Karman Cannula with & without Adopter 10. Sterile Endotracheal Tube Plain & Cuff 11. Tracheotomy Tube 12. Sterile I.V. cannula 13. Sterile Abdominal Drain Kit 14. Close Wound Suction Unit 15. Sterile Nelaton Catheter 16. Sterile Gibbon s Catheter 17. Sterile Nasal Oxygen Catheter 18. Sterile Suction Catheter Plain & Thumb Control 19. Sterile Urotheral Catheter/Rectal Catheter 20. Sterile Umbilical Catheter 21. Sterile Foley Balloon catheter 22. Sterile Chest Drainage catheter 23. Sterile Male External Catheter 24. Sterile female Catheter 25. Sterile Twin Bore Nasal Oxygen Set 26. Sterile L.P. Spinal Needle 27. Sterile Three Way Stop Cock 28. Sterile Extension Tube 29. Sterile A.V. Fistula Needle 30. Sterile Measured Volume Set 31. Sterile Flow Regulator 32. Sterile Hemodialysis Set 33. Sterile Dialysis Catheter/Catheter kit 34. Mini Close Wound Suction Unit G/28/1334 (May 2010 to May 2015)

5 15. M/s. Excel Optics Private Limited, 15A & 15B, 2 nd Street, Loganathan Nagar, Choolaimedu, Chennai M/s. Sharma Surgicals & Engineering Private Limited, , G.I.D.C., Estate, Gujarat 1. Excelens 2. Truelens 3. Novalens 4. Solaris 5. Freedom 6. Novaflex 7. Trufold 1. Bone Screw 2. Bone Plates 3. Pins and Wires 4. Arthroscopy Screw/Implants 5. Spinal Screw 6. Spinal Plate 7. Intern Edulary Nails 8. Interlocking Bolts 9. Locking Plates 10. Other Orthopedic Implants TN (Sept to Sept. 2015) G/28/1339 (May 2010 to May 2015)

6 17. M/s. Rudraksh Pharma & Surgico Private Limited, 176/6, G.I.D.C., Phase-I, opp. Ingersol Rand, Naroda, Ahmedabad Sterile Scalp Vein Set 2. Sterile I.V. Cannula 3. Sterile RYLES Tube 4. Sterile Stomach Tube 5. Sterile Levins Tube 6. Sterile Naso Gastro Tube 7. Sterile Dudenal Tube 8. Sterile Infant Feding Tube 9. Sterile Infant Mucus Extractor 10. Sterile karman Type Cannual 11. Sterile Endotracheal Tube 12. Sterile Nasal Oxygen Catheter 13. Sterile Suction Catheter 14. Sterile Yankur Suction Set 15. Sterile Twin Bore Nasal Oxygen Catheter 16. Sterile Nelaton Catheter 17. Sterile Urthtral catheter, 18. Sterile Gibbous Catheter, 19. Sterile Folly Balloon Catheter 20. Sterile Male External catheter 21. Sterile Umblical Catheter 22. Sterile Chest Drainage Catheter (Thorocic Catheter) 23. Sterile Close Wound Suction Set 24. Sterile Mini Close Wound Suction Set 25. Sterile T.U.R. Set G/28/1348 (Aug to Aug. 2015)

7 18. M/s Amigo Surgicare Pvt. Ltd., Plot No. 780, Sola-Santej Road, Rakanpur, Tal. Kalol, Distt. Gandhinagar M/s Care Group India Block No. 310/E, Village Sim Ka Dabhasa, Tal. Padra, Dist. Vadodara I.V. Cannula [Intravenous Cannula] Amigo Brand Sterile Disposable Single Use Intra Venous Cannula Size: 14G -16G, 18G- 20G, 22G-24G 2. Catheter Sterile Disposable Single Use Ryle s Tube Amigo Brand Sterile Disposable Single Use Ryle s Tube 3. Catheter Sterile Disposable Single Use stomach Tube Amigo Brand Sterile Disposable Single Use Stomach Tube 4. Catheter Sterile Disposable Single Use feeding Tube Amigo Brand Sterile Disposable Single Use feeding Tube 5. Catheter Sterile Disposable Single Use Infant Mucas Extractor Amigo Brand Sterile Disposable Single Use Infant Mucas Extractor 6. Sterile Disposable Single Use Scalp Vein Set Amigo Brand Sterile Disposable Single Use Scalp Vein Set 7. Catheter Sterile Disposable Single Use Abdominal Drainage Kit Amigo Brand Sterile Disposable Single Use Abdominal Drainage Kit 8. Catheter Sterile Disposable Single Use Nasal Oxygen Catheter Amigo Brand Sterile Disposable Single Use Nasal Oxygen Catheter 9. Catheter Sterile Disposable Single Use Suction Catheter Amigo Brand Sterile Disposable Single Use Suction Catheter 10. Catheter Sterile Disposable Single Use Urethral Catheter Amigo Brand Sterile Disposable Single Use Urethral Catheter 1. Foldable Hydrophilic Acrylic Intraocular Lens (Sterile) Having Combination of Overall Length : mm to mm Optic Diameter : 5.00 mm to 7.00 mm Power range : to (0.50 steps) Optic Resolution : Monofocal or Multifocal, Spherical or Aspheric and/or Toric Optic Design : Biconvex, Refractive-Diffractive Modified Aspheric Surface Dialing holes : No holes or 2 dialing holes G/28/1345 (27/07/2010 to 26/07/2010) G/28/1333 (03/05/2010 to 02/05/2015)

8 20. M/s Biotech Vision Care Pvt. Ltd., , Opposite Subham Tel-O-Pack, Khatraj- Vadsar Road, AT& Post Khatraj, Tal. Kalol, Distt. Gandhinagar PMMA INTRA OCULAR LENSES (NON-FOLDABLE CATEGORY) BIOVISION Clear and yellow PMMA Intra Ocular Lenses (Single Piece & Multi Piece) Intra Ocular Lens with Optic Diameter between 5 mm to 7 mm And overall body Diameter between mm 2. PMMA INTRA OCULAR LENSES (NON-FOLDABLE CATEGORY) NUCLEUS Clear and yellow Surface modified PMMA Intra Ocular Lenses (Single Piece) Optic Diameter between 5 mm to 7 mm And overall body Diameter between mm 3. HYDROPHILIC ACRYLIC FOLDABLE INTRA OCULAR LENSES (FOLDABLE CATEGORY) EYECRYL (As a First Brand Name) Clear and yellow hydrophilic acrylic foldable intra ocular lenses (Single Piece & Multi Piece) Intra Optic Lens with Optic Diameter between mm And overall body Diameter between 8.4 mm and 14.0 mm 4. HYDROPHILIC ACRYLIC FOLDABLE INTRA OCULAR LENSES (FOLDABLE CATEGORY) EYECRYL PLUS (As a Second Brand Name) Clear and yellow hydrophilic acrylic foldable intra ocular lenses (Single Piece & Multi Piece) Intra Optic Lens with Optic Diameter between mm And overall body Diameter between 8.4 mm and 14.0 mm 5. HYDROPHILIC ACRYLIC FOLDABLE INTRA OCULAR LENSES (FOLDABLE CATEGORY) EYECRYL PLUS HYDROPHOBIC SURFACE Clear and yellow Surface Modified hydrophilic acrylic foldable intra ocular lenses (Single Piece) Intra Optic Lens with Optic Diameter between mm And overall body Diameter between 8.4 mm and 14.0 mm G/28/1298 (04/04/2009 to 03/04/2014)

9 6. HYDROPHOBIC INTRA OCULAR LENSES (FOLDABLE CATEGORY) EYECRYL PLUS HYDROPHOBIC Clear and yellow hydrophilic acrylic foldable intra ocular lenses (Single Piece & Multi Piece) Intra Optic Lenses with Optic Diameter between mm And overall body Diameter between 8.4 mm and 14 mm

10 21. M/s Sigma Surgical Pvt. Ltd., Plot no. 13, Shree Ram Industrial Estate, B/h. CMC Soni s Chowl Cross Road, Odhav, Ahmedabad Gujarat 1. SORATH BONE SCREW CANNULATED CANCELLOUS SCREWS (C.C.SCREWS) CANCELLOUS SCREWS CORTICAL SCREWS, HIP FIXATION SCREWS END CAP FOR INTERLOCKING NAILS, HERBERT SCREWS INTERFERENCE SCREWS, LOCKING SCREWS FOR INTERLOCKING NAILS, LOCKING HEAD SCREWS MALLEOLAR SCREWS, ORAL MAXILLOFACIAL SCREWS SCHANZ SCREWS, SHAFT SCREWS, TIBIAL POST FIXATION SCREWS 2. SORATH BONE PLATE- CLOVERLEAF PLATES CONDYLAR PLATES, DYNAMIC COMPRESSION PLATES (D.C.P), H PLATES, HIP FIXATION PLATES, HOOK PLATES KNEE FIXATION PLATES, L PLATES, LIMITED CONTACT DYNAMIC COMPRESSION PLATES (L.C.D.C.P.) LOCKING COMPRESSION PLATES (L.C.P) ORAL MAXILLOFACIAL PLATES, RECONSTRUCTION PLATES, SPOON PLATES, T PLATES, TUBULAR PLATES, 3. SORATH INTERLOCKING NAIL- INTERLOCKING NAILS FOR FEMURAL BONE, INTERLOCKING NAILS FOR TIBIAL BONE, INTERLOCKING NAILS FOR HUMRAL BONE, ENDERS NAILS, RUSH NAILS, SQUARE NAILS 4. SORATH WIRES & PINS- K WIRES, S.T.PIN, WASHERS, WIRE REEL, CROSS PINS 5. SORATH SPINAL IMPLANTS- SPINAL HOOKS, SPINAL BONE SCREWS, CAGES, SPINAL BONE PLATES, CONNECTING RODS, CONNECTING BLOCKS 6. SORATH PROSTHESIS- AUSTIN MOORE PROSTHESIS (A.M.P), THOMPSON PROSTHESIS, BIOLAR PROSTHESIS, SHOLDER PROSTHESIS, ELBOW PROSTHESIS, TOTAL HIP PROSTHESIS, TOTAL KNEE PROSTHESIS G/28/1352 (27/09/2010 to 26/09/2015)

11 22. M/s Poly Medicure Ltd., , Sec-59, Faridabad For Export only 1. SURUNEO insta- IV Cannula with small wings & without port 2. SURUFLON insta- IV Cannula with Injection port & wings 3. SUPER FLOW- IV Cannula with Injection port & wings 4. PANACAN- IV Cannula with Injection port & wings 5. MEDPRO- IV catheter with Injection port & wings 6. SURUON PRO- IV Cannula without Injection port & wings 7. SURUFLON PRO- IV Cannula with Injection port & suturable wings 8. SURUNEO- IV Cannula with small wings & without port 9. SURUON- IV Cannula without Injection port & without wings 10. SURUFLON- IV Cannula with Injection port & wings 11. SURUCAN PLUS- IV Cannula with Inegrated Three way stop cock 12. SURUCAN- IV Cannula without Injection port & with wings 13. THOMSON- IV Cannula with Injection port & wings 14. INTROCATH- IV Cannula without Injection port & with wings 15. INTROCATH PRO- IV Cannula with Injection port & with wings 16. NUOVOcath Rapid- IV Cannula without Injection port & without wings 17. IVFLON- IV Cannula with Injection port & wings 18. IVCATH (safety IV catheter)- IV Cannula without port & without wings 19. IVCATH (IV catheter)- IV Cannula without port & without wings 20. Sentrapen safe- Safety IV Cannula without port without wings 21. Sentracen safe- Safety IV Cannula with wings and without injection port 22. Sentraflex safe- Safety IV Cannula with injection port, snap fit cap & suturable wings 23. Sentracath- IV Cannula with 3-way stop cock 24. Sentranovo- IV Cannula with small wing & without port 25. Sentraflex- IV Cannula with small wing & without port 26. Sentraflex- IV Cannula with port & suturable wings 627- B(H) (06/03/2006 to 05/03/2011)

12 27. Sentraflon- IV Cannula with injection port & wings 28. Suruwin- IV Cannula without injection port & wings 29. IVENA- IV Cannula with Injection port 30. IVIVA- IV Cannula without injection port & without wings 31. Icath safety- Safety IV Cannula with wings 32. Icath- IV Cannula with wings 33. UNICAN- IV Cannula without injection port & without wings 34. UNIFLON- IV Cannula with injection port & wings 35. SURUPEN- IV Cannula without port & without wings 36. PROSEMED LORD- IV Cannula without port & without wings

13 23. M/s Inor Medical Products Ltd., Plot No , New G.I.D.C., Gundlav, Distt. Valsad (Gujarat) Easy-Port PUR- IV cannula with injection port & wings 38. Easy-Port FEP- IV cannula with injection port & wings 39. Easy-Pen PUR- IV cannula without injection port & without wings 40. Easy-Pen PUR- IV cannula without injection port & without wings 41. Easy- Cath FEP- IV cannula without injection port & without wings 42. Easy-Cath PUR- IV cannula without injection port & without wing 43. Easy-Cath W PUR- IV cannula with wing & without injection port 44. Easy-Cath W FEP- IV cannula with wing & without injection port 45. Easy-Cath W Neo FEP- IV cannula with small wing & without injection port 46. Easy- Port Safety PUR- Safety IV cannula with injection port & wings 47. Easy- Port Safety FEP- Safety IV cannula with injection port & wings 48. Easy- Pen Safety PUR- Safety IV cannula without injection port & without wings 49. Easy- Port Safety FEP- Safety IV cannula with injection port & without wings 50. Easy- Cath Safety FEP- Safety IV cannula without injection port & without wings 51. Easy- Cath Safety PUR- Safety IV cannula without injection port & without wings 52. Easy- Cath W Safety PUR- Safety IV cannula with wings & without injection port 53. Easy- Cath W Safety FEP- Safety IV cannula with wings & without injection port 1. FH ORTHOPEDICS- AUSTIN MOORE HIP PROSTHESIS 2. FH ORTHOPEDICS- BONE SCREW DHS SCREWS 3. FH ORTHOPEDICS- BONE PLATES (A) DHS PLATES 135 (Degree) (B) DCS PLATES G/28/1313 (18/08/2009 to 17/08/2014)

14 24. M/s Aurolab, No. 1, Sivagangai Main Road, Veerapanjan, Madurai For export only 1. SEELENS (Poly methyl methacrylate) 2. SEEFOLD (Hydrophilic foldable poly hydroxyl ethyl Methacrylate with broad C haptic) 3. SEEFLEX (Hydrophilic foldable poly hydroxyl ethyl metacrylate with dual haptic) TN (13/08/2009 to 10/08/2014) 25. M/s Med Plus India, Plot No. 1220, Phase-III, Near V Trans Transport, G.I.D.C. Vatva, Ahmedabad (Gujarat) 26. M/s ilife Medical Devices Pvt. Ltd. # 86, SECTOR 56, Phase-IV, I.E. Kundli, Sonepat M/s Harsoria Healthcare Pvt. Ltd., , Phase-IV, Udyog Vihar, Gurgaon, Haryana 1. All Type of Bone Screws- Brand : MPI 2. All Type of Bone Plates- MPI 3. All Type of PINS AND WIRES- MPI 4. All Type of ENDO PROSTHESIS- MPI 5. All Type of Intramodular- MPI 6. All Type of OFSPINE IMPLANTS- MPI 7. All Type of CERVICAL IMPLANTS 1. AG-CATH- Sterile Intravenous Cannula 2. AG-CATH- Sterile 3 way stop cock 1. Sterile Disposable Safety IV Cannula with Catheter & with injection valve for Single use only 2. Sterile Disposable Safety IV Cannula with Catheter & without injection valve for Single use only 3. Sterile Disposable IV Cannula with Catheter & without injection valve & for Single use only G/28/1353 (15/10/2010 to 14/10/2015) 673-B (H) (13/08/2010 to 14/08/2015) 637-B (H) (17/09/2007 to 18/09/2011) 28. M/s Hardik International, Plot no. G /A, Lodhika G.I.D.C. Kishan Gate, Kalawad Road, Metoda, Distt. Rajkot 1. HARDIK- BONE SCREWS (NON STERILE) 2. HARDIK- BONE PLATES (NON STERILE) 3. HARDIK- PINS AND WIRES (NON STERILE) 4. HARDIK- ENDOPROSTHESIS (NON STERILE) 5. HARDIK- IM NAILS (NON STERILE) 6. HARDIK- SPINE IMPLANTS (NON STERILE) 7. CERVICAL IMPLANTS (NON STERILE) G/28/1356 (30/10/2010 to 29/10/2015)

15 29. M/s Biorad Medisys Pvt. Ltd., # 660, 1 st & 2 nd Floor, Eshwari Industiral Estate, Hulimavu, Bannerghatta Road, Bangalore M/s BioRad Medisys Pvt. Ltd., 48/3 & 48/7, Sus Pashan Road, Pune M/s R.R. Surgicals, 11/12 Merchant Industrial Estate, Survey No. 10, Building, No. 1, Near Syndicate Bank, Waliv, Vasai (East) , Dist. Thane 32. M/s Harsoria Health Care (P) Ltd., Phase-IV Udyog Vihar, Gurgaon (Hr) 1. Double J Shape Catheter, Ureteral Stent, Double J Stent, Mono J Stent (Indovasive) 2. Urethral Tumor Catheter, Endopyelotomy stent, (Indovasive) 3. Urethral Catheter, Urethral stent, Hypospadias Catheter (Indovasive) 4. PCN Catheter, PCN Catheter with Needle, PCN Catheter with Locking, Nephrostomy Catheter (Indovasive) 5. Malecot Catheter, Re-entry Malecot catheter, suprapubic catheter (Indovasive) 6. Ureteral Catheter, Selective catheter (Indovasive) 7. Nottingham one step catheter (Indovasive) 8. Duel Lumen Catheter (Indovasive) 9. Biliary Drainage Catheter, Biliary Pancreatic Stent (Indovasive) 10. Nasal Biliary Drainage Catheter (Indovasive) 11. Jejunal Feeding Catheter Tube (Indovasive) 12. Bilbao Dotter Catheter (Indovasive) 13. Percutanous Transhepatic Biliary Drainage Catheter (PTBO Catheter) (Indovasive) 14. IUI Catheter/IUI Catheter Cannula with/without Syringe (Indovasive) 1. Indus Total Knee Prosthesis- Cr. Co & UHMDPE 2. Indus Partial Hip Prosthesis (SMP) SS 316 L 3. Indus Total Hip Prosthesis CR.CO Alloy/ UHMDPE/ SS 316 L 1. Bone Screws 2. Bone Plates 3. Intra Medullary Nails 4. Pins and Wires 5. Spinal Implants 1. INFLO PLUS - Sterile Disposable IV Cannula with Catheter & with injection valve for single use only KTK/28/385/2010 (16/08/2010 to 15/08/2015) PD/124, (31/07/2010 to 30/07/2015) KD/492, (13/08/2010 to 12/08/2015) 637-B(H) Valid upto 18/09/2011)

16 33. M/s Royal Surgical Pvt. Ltd., Plot no. 832, NR. Ganesh Rubber, Santej, Tal-Kalol, Dist. Gandhinagar Generic Sterile Scalp Vein Set For Single Use Only Size (Gauge) 2. Generic- Sterile Measure Volume Set For Single Use Only 3. Generic- Sterile I.V. Cannula For Single Use Only 4. Generic- Sterile I.V. Flow Regulator For Single Use Only 5. Generic- Sterile Peritoneal Dialysis Set For Single Use Only 6. Generic- Sterile Extension Line - With Three Way Stop Cock, For Single Use Only 7. Generic- Sterile High Pressure Monitoring Line For Single Use Only 8. Generic- Sterile T.U. R Set For Single Use Only 9. Generic- Sterile Closed Wound Suction Unit For Single Use Only 10. Generic- Sterile Tracheostomy Tube (with/without Cuffed) For Single Use Only 11. Generic- Sterile Endotracheal Tube (with / Without Cuffed) For Single Use Only 12. Generic- Sterile Infant Mucus Extractor For Single Use Only 13. Generic- Sterile Umbilical Cord Clamp For Single Use Only 14. Generic- Sterile Corrugated Drainage Sheet For Single Use Only 15. Generic- Sterile Suction Catheter For Single Use Only 16. Generic- Sterile Urethral Catheter For Single Use Only 17. Generic- Sterile Nelaton Catheter For Single Use Only 18. Generic- Sterile Ryle s Tube For Single Use Only 19. Generic- Sterile Infant Feeding Tube For Single Use Only 20. Generic- Sterile Chest Drainage Catheter For Single Use Only 21. Generic- Sterile Umbilical Catheter (Cannula) For Single Use Only 22. Generic- Sterile Abdominal Drainage Kit For Single Use Only 23. Generic- Sterile Karman Cannula With/ Without Adapter For Single Use Only 24. Generic- Sterile Nasal Oxygen Catheter For Single Use Only G/28/135, 27/08/2010 to 26/08/2015)

17 34. M/s Meril Life Sciences Pvt. Ltd., Near G.M. Bilakhia Stadium, Muktanand Marg, Chala, Vapi , Gujarat 35. M/s Polymer Technologies International (EOU) Block no. 310/C, Village Sim ka Dabhasa, Tal. Padra, Dist. Vadodara Nexgen Cobalt Chromium Coronary Stent and Stent System (Bare metal Coronary Stent System) 2. Osum Cobalt Chromium Coronary Stent and Stent System (Bare metal Coronary Stent System) 3. Crypton Stainless Steel Coronary Stent and Stent System (Bare metal Coronary Stent System) 4. Biomime Sirolimus Eluting Coronary Stent and Stent System (Biodegradable Polymer Based Sirolimus Eluting Coronary Stent and Stent System) G/28/1273, issue dated 20/06/2008) 1. Foldable Hydrophobic Yellow Intraocular Lens (Sterile) G/28/1321, valid upto 17/12/2014) 36. M/s Nebula Surgical Pvt. Ltd., G.I.D.C., G/ , B/h Telephone Tower, Metoda, Distt. Rajkot (Gujarat) 37. M/s MIV Therapeutics (India) PVT. LTD., 139-B, Surat Special Economic Zone, Diamond Park, GIDC, Sachin, Surat Bone Screws (Non Sterile) 2. Bone Plates (Non Sterile) 3. Pins and Wires (Non Sterile) 4. Endoprosthesis (Non Sterile) 5. Im Nails (Non Sterile) 6. Spine Implants (Non Sterile) 7. Cervical Implants (Non Sterile) 1. Second Brand- Xperia Coronary Stent and Stent System 2. Third Brand Superia Coronary Stent and Stent System 3. Third Brand Flexia Coronary Stent and Stent System 4. Fourth Brand ULTI S- Core Coronary Stent and Stent System 5. Fourth Brand ULTII Core Coronary Stent and Stent System G/28/1355, 29/10/2010 to 28/10/2015) G/28/1355, valid upto 05/10/2012)

18 38. M/s. Green Surgicals Private Limited, Plot No , GIDC Savli Industrial Estate, Manjusar, Vadodara , Gujarat 1. Bone Screws 2. Bone Plates 3. IM Nails 4. Pins & Wires 5. Staples 6. Washers & Buttons 7. Hemi Endo Prosthesis 8. Spinal Implants, Mesh & cages 9. Knee Surgery Implants 10. Sets of Implsnts 11. Peek & Carbon Fibre Reinforced Polymer (CFRP) Implants 12. Bone & Bone Substitute 13. Bone Cements 14. Maxillophysical Implants G/28/1331, valid upto 21/03/2015)

Statement Indicating Status on Grant of Approval by CLAA for Manufacture of Notified Medical Devices. (Jan to August 2011)

Statement Indicating Status on Grant of Approval by CLAA for Manufacture of Notified Medical Devices (Jan. 2011 to August 2011) # Name of the Manufacturer Product Licenced by CLAA Manufacturing Licence