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Registration Certificates issued for the Medical Devices alongwith their manufacturing sites and Indian Authorized

Agents from Jan. 2011 to August 2011

S. No.

Name of Indian Agent

Name of Manufacturer

Name of the Device File No. R. C. No. Validity of the Registration Certificate

1 M/s Sahajanand Medical Technologies Pvt. Ltd., Sahajanand House, Parsi Street, Saiyedpura, Surat- 395003, Indai

M/s. Natec Medical Ltd., Maeva Centre Building, Business Park, Ebene, Reduit, Maruitius

Catheter:PTCA Catheter: Tamarin Blue (Non Sterile)

31-273-MD/2007-DC (Re-Registration 2009)

MD-273 31-12-2013

2 M/s VSY Ophthalmic India Pvt. Ltd., 860/1-B, GIDC Estate, Nr. ABB Goods Gate, Makarpura, Vadodara- 390010, Gujarat

M/s VSY Biotechnology-VSY Biyoteknoloji ve IIac San. A.S. of Ataturk Mah., Sulun c., Kamilbey Sok No. 4, Atasehir, Istanbul, Turkey

1. ACRIVA Ultra Definition Intra Ocular Lents

2. ACRIVA Reviol Multifocal Intra Ocular Lens

3. OCUVA Aspheric Intra Ocular Lens

4. OCUVA Spheric Intra Ocular Lens

31-824-MD/2010-DC MD-824 31-12-2013

3 M/s India Medtronic Pvt. Ltd., 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Anheri-Ghatkopar Link Road, Andheri (E), Mumbai- 400093

M/s Medtronic Inc., 710 Medtronic Parkway N. E. Minneapolis MN 55432 USA having manufacturing premises at M/s Medtronic ATS Medical Inc., 3905 Annapolis Lane, Suite 105 Minneapolis, MN – 5547, USA

1. Open Pivot Heart Valve2. Open Pivot Aortic Valved

Graft (AVG)

31-892-MD/2010-DC MD-892 31-12-2013

4 M/s B. Braun Medical India Pvt. Ltd., 5th Floor, East Quadrant,

M/s B. B raun Melsungen AG, Carl-Braun- Strasse 1,

1. Intrafix-IV Infusion administration sets vented for pressure and

31-146-MD/2006-DC (Re-Registration 2009) (End. 1)

MD-146 30-11-2012

1

The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (E), Mumbai- 400051

34212 Melsungen, Germany

gravity infustions

5 M/s Edward Lifesciences (India) Pvt. Ltd., E.F. 201-204, Remi Biz Court, Plot No. 9, Off Veera Desai Road, Andheri West, Mumbai- 400058

M/s Edward Lifesciences LLC, One Edwards Way, Irvine CA, USA 92614-5686

1. Carpentier-Edwards Bioprosthetic Valved Conduit

2. Edwards MC Tricuspid Annuloplasty System

31-93-MD/2006-DC (Re-Registration 2010) (End. 1)

MD- 93 31-01-2013

6 M/s Boston Scientific International B.V., 100A, The Capital Court, Olof Plame Marg, Munirka, New Delhi- 110067

M/s Boston Scientific Corporation, Boston Scientific Place, Natick, Massachusetts 01760-1537, USA having factory premises at M/s Boston Scientific Ireland Ltd., Ballybrit Business Park, Galway, Ireland

1. WallFlex Enteral Colonic/ Duodenal Stent System

31-41A-MD/06-DC (End. 2)

MD-41A 31-03-2013

7 M/s Abbott Medical Optics Pvt. Ltd., No. 91, G.N.T. Road, Madhavaram, Chennai- 600110

M/s Abbott Medicals Optics Inc., 1700E St. Andrew Place, Santa Ana, California 92705, USA having factory premises at M/s AMO Manufacturing Spain, S.L. Crta. Fuencarral A, KM 15.4, 28100 Alcobendas (Madrid0, Spain

1. Blink Intensive Tears 31-737-MD/2009-DC MD-737 31-12-2013

8 M/s B. Braun Medical (India) Pvt. Ltd., 5 th Floor , East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra

M/s B. Braun Medical, 204 Avenue du Marechal Juin-BP 331, 92107 Boulogne, Cedex, France having factory premises at

Needles for Implantable access ports

1. Surecan2. Cytocan


MD- 393 31-12-2013

2

(East), Mumbai- 400051

M/s B. Braun Medical Industries Sdn. Bhd., Bayan Lepas Free Industrial Zone, 11900 Penang, Malaysia

9 M/s RFCL Ltd., A-3, Okhla Industrial Area, Phase-I, New Delhi

M/s Biokit S.A. Can Male s/n, 08186, Llica d Amunt, Barcelona, Spain

1. Bioelisa HBsAg 3.0 6-6/CD-35/2009-DC (Re-Reg 2009) (End 01)

CD-31 31-05-2012

10 M/s Epsilon Eye Care Pvt. Ltd., 6B-301 Shweta Asha Nagar, Western Express Highway, Kandivali East, Mumbai - 400101

M/s Aaren Scientific Inc., 4290 E. Brickell Street, Building A, Ontario, California 91761 USA

1. Oii PMMA (Intraocular Lenses)

2. Oii Heparin PMMA (Intraocular Lenses)

3. Oii Biovue (Intraocular Lenses)


MD-14 30-06-2012

11 M/s Becton Dickinson India Pvt. Ltd., 5th Floor, Singnature Towers II, South City-1, Gurgaon- 122001 Haryana

M/s Becton Dickinson and Company, BD Medical Diabetes Care, 1 Becton Drive, Franklin Lakes, New Jersey 07417, having factory premises at M/s BD Medical Diabetes Care, 1329 West Highway # 6, Holdrege, Nebraska, 68949, USA

1. Alcohol Swab 31-825-MD/2010-DC MD-825 14-12-2013

12 M/s. Labindia Healthcare Private Limited, 372 Udyog Vihar, Phase- 2, Gurgaon, 122016, Haryana

M/s.KCI USA Inc., 4958 Stout Drive San Antonio, TX 78219 USA having factory premises at M/s Polymedics BVBA, 1031 Ambachtslaan, Peer, Belgium 3990

1. VAC WhiteFoam Small & Large

31-792-MD/2010-DC MD- 792 31-12-2013

13 M/s. St. Jude Medical India Private Limited,

M/s. St. Jude Medical, 14901 De Veau Place

1. Engage Family Introducers

31-22-MD/2006-DC (Re-Registration

MD- 22 30-06-2012

3

A&B, 2nd Floor, “Brij Tarang”, Greenlands, Begumpet, Hyderabad 500016

Minnetonka, MN 55345-2126 USA

2009) (End 3)

14 M/s Baxter (India) Pvt. Ltd., 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase II, Gurgaon 122002

M/s Baxter Healthcare Corporation 1900 N. Highway 201 Monutain Home, ar 72653-2497

1. Minicap Extended Life Transfer Set

31-730-MD/2009-DC MD- 730 31-12-2013

15 M/s Tyco Healthcare India Pvt. Ltd., “DOSHI TOWERS” 6th Floor, Doshi twoers, Poonamallee High Road, Chennai- 600010

M/s Mediquip Sdn. Bhd. PO Box 2501700 Kangar, Perlis, Malaysia

1. Kendall Curity Latex Foley Catheter


MD- 333 31-12-2013

16 M/s. Globus Medical India Private Limited, New No. 3, Sriram Nagar, South Street, Alwaret, Chennai- 600018

M/s. Globus Medical, Valley Forge Business Centre 2560 General Armistead Avenue Andubon, PA 19403, USA

1. Microfuse Bone Void Filler (Spine Indications), Sterile

2. H-Link Integrated Rod3. Transition Stabilization

System STERILE Implant4. Nilo Corpectomy Spacer5. Patriot Singature TLIF

Spacer6. Revolve Stabilization

System7. VIP Anterior Cervical

Plate System8. Corridor Fixation System

31-277-MD/2006-DC (Re-Registration 2010) (End 1)

MD- 277 28-02-2013

17 M/s. Baxter India Private Limited, 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase-II, Gurgaon-122002

M/s. Baxter Healthcare Corporation, 21026, Alexander Court, Hayward, CA 94545, USAHaving factory premises at M/s.

1. Curved Applicator Tip 8cm & 10cm

31-734A-MD/2009-DC (Re-Registration 2011)

MD-734A 14-01-2014

4

Baxter Healthcare Corporation, 21026, Alexander Court, Hayward, CA 94545, USA

18 M/s. Smith & nephew Healthcare Private Limited, BG 1-3, 15-17 Rajlaxmi Commercial Complex, kalher Village, Thane-Bhiwandi Road, Thane-421302

M/s. Smith & Nephew Orthopaedics Limited, 1 Kingmaker Court, Warwick Technology Park, Gallows Hill, Warwick, CV34 6 WG, UK having factory premises at M/s. Smith & Nephew Orthopaedics Limited, Aurora Spa Park, Harrison Way, Leamington Spa, Warwick, DV31 3HL, UK

Birmingham Hip Resurfacing System

31-441-MD/2008-DC (Re-Reg. 2010)

MD-441 31-03-2014

19 M/s. Prime Surgicals, 3/15 Asaf Ali Road, New Delhi-2

M/s. Curamed Opthalmics, Voorstraat 57, 4132 AN, Vianen, Netherlands

Curamed Intraocular Lens Hydrophilic Acrylic

31-152-MD/2006-DC (Re-Reg. 2010)

MD-152 14-02-2014

20 M/s. Alpha and Omega Diagnostics India Limited, Rajmahal 13, Bhuleswar Road, Mumbai-400002

M/s. Labotect GmbH, labour technik-Gottingen, Wille-Eicher Str. 25, D-37079 Gottingen, Germany

Embryo Transfer Catheter 31-269-MD/2006-DC (Re-Reg. 2010)

MD-269 14-02-2014

21 M/s. DePuy Medical private Limited, 64-66 Senapati Bapat Marg, mahim, Mumbai-400016

M/s. DePuy Orthopaedics, Inc PO BOX 988, 700 Orthopaedic Drive, Warsaw, Indiana 46581-0988, USA having factory premises at M/s.

1. PFC Tibial Trays-Standard & Modular

2. Apex Hole Eliminator3. Articul/Eze Heads4. Duraloc Hip System-Poly

Liners & Cups5. PFC Sigma Toal Knee

Replacement

31-852-MD/2010-DC MD-852 31-01-2014

5

Johnson & Johnson Medical (Suzhou) Limited, No. 299, Chang Yang Street, Suzhou Industrial Park, Suzhou Jiangsu 215126, China

6. Global Shoulder Systems7. Screws: Cortical Screws,

Cancellous Screws and pinnacle Screws

22 M/s. WorldMed Equipments Private Limited, Office No. 49 & 50, 3rd Floor, Property no. WZ 26, Village Nangli Jalib, janak Puri, New Delhi-110058

M/s. CID S.r.l., Strada per Crescentino snc, 13040, Saluggia (VC), Italy

1. Janus Optima Carbostent2. Brio Pegaso SCRX3. Pro HP Pegaso

31-06-MD/2006-DC (Re-Reg. 2009) (End 01)

MD-06 14-04-2013

23. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-400036

M/s. Johnson & Johnson International, C/o European Logistics Centre, Lenneke Marelaan 6, BE-1932 St Stevens Woluwe, Belgium having factory premises at M/s. Johnson & Johnson Medical GmbH, Robert Koch Strasse 1, D-22851 Norderstedt, Germany

1. VICRYL Polyglactin 910 Violet Dyed and Undyed Synthetic Absorbable Sutures

2. VICRYL Plus Suture with Triclosan

3. VICRYL Rapide Polyglactin 910 Violet Dyed & Undyed Synthetic Absorbable Sutures

4. PROLENE monofilament Polypropylele Blue Dyed & Undyed Synthetic non-absorbable sutures

31-816 (FF-319)-MD/08-DC (Re-Reg. 2011)

MD-816 (FF-319)

14-02-2014


M/s. Medinol Limited, PO Box 45026, Back Tech Bldg, 4th Floor, Har-Hotzvim B, Hartom Street 8, Jerusalem 91450, Israel

PRESILLION Plus CoCr Coronary Stent on RX System (Sterile) (PRESILLION Plus Stent System)

31-788-MD/2010-DC MD-788 14-02-2014

25. M/s. Johnson & Johnson Limited, 30 Forjett Street, Mumbai-

M/s. Cordis Corporation, 14201, North West 60th

Emboli Capture Guidewire System: Angioguard XP and Angioguard RX

31-859A-MD/2010-DC MD-859A 31-01-2014

6

400036 Avenue, Miami Lakes, Florida 33014, USA having factory premises at M/s. Lake Region Medical, 340 lake Hazeltine Drive Chaska, MN 55318, USA


M/s. Codman & Shurtleff Inc, 325 Paramount Drive Raynham, Massachusetts, USA

Duraform Dual Graft Implant (Absorbable collagen-Sterile)

31-815 (A)- (FF-321)-MD/2008-DC (Re-Reg. 2010)

MD-815 (A) (FF-321)

31-03-2014

27. M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093

M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. Medtronic Ireland parkmore Business park, West Galway, Ireland

1. Endeavor Zotarolimus Eluting Coronary Stent System

2. Endeavor-Sprint-Zotarolimus-Eluting RX Coronary Stent System

3. Endeavor Resolute Zotarolimus Eluting Coronary Stent System

4. Assurant Cobalt Over-The wire lilac Stent System

31-64-MD/2006-DC (Re-Reg. 2009)

MD-64 31-07-2012


M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. Medtronic Ireland parkmore Business park, West Galway, Ireland

1. Talent Abdominal/AUI Stent graft with Xcelerant Hydro Delivery System

2. Valiant Stent Graft with Xcelerant Delivery System

31-64-MD/2006-DC (Re-Reg. 2009) (PT-IV)

MD-64 31-07-2012

29. M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-

M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at

1. Launcher Guide Catheter2. Vascular Diagnostic

Catheter (a) SiteSeer(b) ProFlow

3. PTCA Guidewires

31-63-MD/2006-DC (Re-Reg. 2009)

MD-63 31-08-2012

7

Ghatkopar Link Road, Andheri East, Mumbai-400093

M/s. Medtronic Vascular 37A, Cherry Hill Drive, Danvers, MA 09123, USA

4. Angiographic Guidewires5. Export and Export XT Aspiration Catheters6. Guardwire Occlusion and Aspiration System7. Woven Angiographic Catheters8. Sherpa NX Guiding Catheters


M/s. Medtronic Sofamore Danek USA Inc, 1800 Pyramid Place, Memphis, TN 38132, USA having factory premises at M/s. Medtronic Sofamore Danek Manufacturing 2500, Silveus Crossing Waresaw, Indiana, USA 46582

1. Atlas Cable System2. Brayan Cervical Disc

System3. MAV Motion Segment

Replacement-A-MAV & O-MAV Artificial Disc Replacement

4. LT-CAGE Lumber Tapered Fusion Device

5. Prestige LP Cervical Disc System

6. ATLANTIS Anterior Cervical Plate System

7. BASIS Spinal System8. CD HORIZON Spinal

System9. Pyramesh C Mesh10. Pyramesh Implant

System11. Vertek Reconstruction

Implants12. Zephir Anterior Cervical

Plate System13. Dynamic Compression

SMA Stapple System14. TSRH Spinal System15. UCSS Universal

Cannulated Cortical Bone Screw

16. Colorado 2 Spinal System

31-69-MD/2006-DC (Re-reg. 2009)

MD-69 31-01-2013

8


M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. C.R. Bard Inc, 289 Bay Road, Queensbury, NY 12804, USA

Rashkind Septostomy Catheter 31-341-MD/2007-DC (Re-Reg. 2010)

MD-341 14-08-2013


M/s. Medtronic Sofamore Danek USA Inc, 1800 Pyramid Place, Memphis, TN 38132, USA having factory premises at M/s. Medtronic Sofamore Danek USA Inc, 4340 Swinnea Road, Memphis TN 38118

Infuse Bone Graft 31-69B-MD/2006-DC (Re-Reg. 2009)

MD-69B 14-04-2013


M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s. Medtronic vascular, 37A, Cherry Hill Drivew, Danvers, MA 09123, USA

Total 5 Products 31-63-MD/2006-DC (Re-Reg. 2009) (End 01)

MD-63 31-08-2012


M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN 55432, USA having factory premises at M/s Medtronic Ireland parkmore Business Park West Galway, Ireland

Sprinter Legend Over the Wire Balloon Dilatation Catheter

31-64-MD/2006-DC (Re-Reg. 2009) (PT-V)

MD-64 31-07-2012

9

35. M/s. Allergan Healthcare India Private Limited, Level 2, Presige Obelisk, No. 3 Kasturba Road, Bangalore-560001

M/s. Allergan, 31, rue des Colonnes du Trone, 75012, Paris, France having factory premises at M/s. Allergan Route de promery, Zone Artisanale de pre-Mairy, 74370 Pringy, France

Hyaluronic Acid with Lidocaine 31-483-MD/2008-DC (End 01)

MD-483 31-05-2012

36. M/s. KMS Medisurgi Private Limited, 44, Mangaldas Road, Bulakhidas Building, Ground Floor, Mumbai-400002

M/s. Mascia Brunelli s.p.a. Vle. Monza, 272.20128 Milano-Italy

Haemostatic Gelatin Sponge (Cutanplast)

6-4/FF/35/04-DC (PT) (Re-Reg. 2010)

FF-276 31-01-2014

37. M/s. S.R. International, 801, Manjusha, 57 Nehru Place, New Delhi-110019

M/s. Arcadophta Sarl, 11, rue Antoine Ricord, 31100 Toulouse, France

Arceole Set Multidose Kit (C3F7, SF6, C2F6) (Intraocular Gases)

6-4/FF/40/06/DC (Re-Reg. 2010) (End 01)

FF-425 30-09-2013

38. M/s. B. Braun Medical India Private Limited, 5th Floor, East Quadrant, The IL & FS Financial Centre, Bandra Kurla Complex, Bandra (E), Mumbai-400051

M/s. B. Braun Melsungen AG, Carl-Braun-Str. 1, 34212, Melsungen, Germany having factory premises at M/s. B. Braun Melsungen AG, Vascular Systems, Sieversufer 8, 12359, Berlin, Germany

Arteriofix-Arterial Catheter Sets 31-687-MD/2009-DC (End 02)

MD-687 30-11-2012

39. M/s. Boston Scientific International B.V., 100A, The Capital Court, Olof Plame Marg, Murirka, New Delhi-110067

M/s. Boston Scientific Corporation, Boston Scientific Place, Natick, Massachusetts 01760-1537, USA having factory premises at M/s. Availmed S.A. de C.V. A. Pasaeo

1. Wiseguide Catheter 2. Impulse Angiographic

Catheter 3. Mach 1 Guide Catheter

31-166-MD/2006-DC (Re-Reg. 2009)

MD-166 14-02-2014

10

Reforma No. 8950 Int. G1ByG1H, Col. Fraccionamiento Rubio, C.P. 22116, Le Mesa, Tijuana, Baja, California

40. M/s. Smith & Nephew Healthcare Private Limited, C/O Shebros Agencies, Minaxi Industrial Estate, Gala-7, Bldg-1, Naikpada, W.E. Highway, Vasai9E), Maharashtra-410208

M/s. Smith & Nephew Inc, Orthopedic DEivision, 1450 Brooks Road, Memphis, TN 38116, USA

1. Echelon Hip System 2. Synergy Hip System 3. Reflection Acetabular

System 4. Genesis II Knee System 5. VersaBond and

VersaBond AB Bone Cements

6. Journey Knee System 7. Legion Knee System 8. Tandem Hip System 9. R3 Acetabular System

31-779-MD/2010-Dc MD-779 14-02-2014

41. M/s. Baxter India Private Limited, 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase-II, Gurgaon-122002

M/s. Micromedics Inc, 1270 Eagen Industrial Road, Suite #120 St. Paul, MN 55121, USA

1. Duplospray MIS Applicator[5mmX30cm, 5mmX40cm, 5mmX20cm, 20cm, 30cm]

2. Duplotip Dual Lumen Cannula [20 GA X 10.4cm, 20 GA X 26.4cm, 5MMDia X 31.8cm]

31-733-MD/2009-Dc MD-733 31-01-2014

42 M/s. Baxter India Private Limited, 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase-II, Gurgaon-122002

M/s. Baxter Healthcare Corporation, 17511 Armstrong Avenue Irvine, California 92614, USA

Floseal Endoscopic Applicator 31-719-MD/2009-DC MD-719 14-02-2014

43. M/s. Event Medi Systems, 218 Vishal Towers, District centre, Janakpuri, New Delhi-110058

M/s. Conic Vascular Technology, SA Via G. Curti, 5 CH-6900 Lugano, Switzerland

1. Clever PTCA Balloon Catheter

2. Conic One PTCA Balloon Catheter

31-798-MD/2010-DC MD-798 31-01-2014

11

44. M/s. Alcon Laboratories India Private Limited, Unit No. 502, Tower “D”, 5th

Floor, RMZ Infinity, Benniganahalli, Old Madras Road, Bangalore-560016

M/s. Alcon Laboratories Irelands Limited,m Cork Business and technology Park, Model Farm Road, Cork Ireland

AcrySof IQ ReSTOR Multifocal Intraocular lens

31-364-MD/2006-DC (Re-Reg. 2010) (End 01)

MD-364 14-09-2013

45. M/s. Edwards Lifesciences India Private Limited, E.F. 201-204 Remi Biz Court, Plot o. 9, Off Veera Desai Road, Andheri (W), Mumbai-400058

M/s. Edwards Lifesciences Technology Sarl, State Road 402, KM 1.4, Industrial Park, Anasco, Puerto Rico 00610-1577

1. Advance venous Access products

2. AVA 3Xi Devices3. Central Venous Oximetry

Catheters (PreSep Oximetry Catheters)

4. Swan-Ganz Cath Lab (Non-Thermodilution)

5. Swan-ganz Oximetry and Volumetric Catheters (Oximetry Catheters)

6. Swan-Ganz CCO and CCOmbo Catheters (Swan-Ganz continuous cardiac output (CCO)) Thermodilution Catheters

7. Fogarty Catheters (Embolectomy) Catheters, Thrombectomy Catheters, Adherent Clot Catheter)

31-91-MD/2006-DC (Re-Reg. 2009) (End 02)

MD-91 31-03-2013

46. M/s. St. Jude Medical India private Limited, A & B, 2nd Floor, Brij Tarang, Greenlands, Begumpet, Hyderabad-500016

M/s. Hansen Medical Inc, 800 East Middlefield Road, Mountain View CA 94043

Artisan Control Catheter 31-812-MD/2010-DC MD-812 31-01-2014

47. M/s. Heart Beat Intervention Private

M/s. Minvasys, 7, rue du Fosse Blanc-92230

1. PTCA Catheters2. PTA Catheters

31-275-MD/2007-D (Re-Reg. 2010)

MD-275 14-01-2014

12

Limited, 9, Lower Ground, Narayan Darshan Apartment, Opp. Rupam Cinema, Salabatpura, Surat-395002, Gujarat

Genevilliers, France 3. Intra Coronary Stents

48. M/s. Access Devices, 28, 12th Cross, Indiranagar 1st Stage, Bangalore-560038

M/s. Districlass Medical SA, 16, Rue Paul Bert 42000 Saint Etienne-France having factory premises at M/s. Districlass Medical SA, B.P. 14, 69970 Chaponnay, France

Districath Implantable Catheter Ports

31-97-MD/2006-DC (Re-Reg. 2010)

MD-97 14-02-2014

49. M/s. Vishal Surgical Equipment Co. Private Limited, Melaram Complex, 23, Wallers Road, Chennai-600002

M/s. Gebruder martin GmbH & Co, KG Ludwigstaler Strasse 132, 78532 Tuttlingen, Germany having factory premises at M/s. Karl Leibinger medizintechnik GmbH & Co., KG, Kolbinger Str. 10, D-78570, Muelhelm a.D./Germany

1. Screws, Plates, mesh, Distractors of various sizes-Titanium

2. Resorbx Screws, Plates, Mesh, Sonic-weld RX Pins

3. Screws, Plates, Mesh, Distractors of various sizes-Titanium

4. Screws, Plates, Mesh, Distractors of various sizes-Stainless Steel

31-390-MD/2007-DC (Re-Reg. 2010)

MD-390 14-02-2014

50. M/s. Evolutis India Private Limited, 185-R, Alhad, 1s Floor, P.K. Road, Mulund (W), Mumbai-400080

M/s. Evoluis, Avenue De La Liberation-42720, Briennon, France

Total 8 products 31-282-MD/2006-DC (Re-Reg. 2010)

MD-282 14-02-2014

51. M/s. Zimmer India Privated Limited, Plot No. B & B1, vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016

M/s. Zimmer GmbH, Sulzer Allee 8, CH 8404, Winterthur, Switzerland

Trofix Trochanteric Fixation Plating System

31-171-MD/2006-DC (Re-Reg. 2009) (End 01)

MD-171 31-07-2012

13

52 M/s. Zimmer India Privated Limited, Plot No. B & B1, vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016


Zimmer MMC Cup 31-171-MD/2006-DC (Re-Reg. 2009) (End 02)

MD-171 31-07-2012


M/s. Ethicon LLC, Road 183 Km 8.3 San Lorenzo, Puerto Rico 00754

1. Prolene (Polypropylene) Soft Mesh

2. Gynecare Gynemesh PS

31-738(A)-MD/2009-DC End 01

MD-738(A)

28-02-2013

54. M/s India Medtronic Pvt. Ltd., 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Anheri-Ghatkopar Link Road, Andheri (E), Mumbai- 400093

M/s Medtronic Inc., 710 Medtronic Parkway N. E. Minneapolis MN 55432 USA having manufacturing premises at M/s Medtronic Ireland Parkmore Business Park West Galway, Ireland

Integrity Rapid Exchange Coronary Stent System

31-64-MD/2006-DC (Re-Reg. 2009) (End 06)

MD-64 31-07-2012

55. M/s. Hansraj Nayyar Medical India, 1416, Maker Chambers V, Nariman Point, Mumbai-400021

M/s. Smiths Medical ASD Inc, 201 West Queen Street, Southington, Connecticut 06489, USA

ProtectIV Plus Safety I.V. Catheter

31-809-MD/2010-DC MD-809 14-02-2014

56. M/s. baxter India Private Limited, 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase-II, Gurgaon-122002

M/s. baxter Healthcare SA, 8010 Zurich, Switzerland having factory premises at M/s. Plan 1 Health Srl, Via Solari 5, 33020, Amrao (UD), Italy

Healthport Implantable Access Port System (Venous, Arterial, Spinal)

31-159-MD/2006-DC (Re-Reg. 2010)

MD-159 28-02-2014

57. M/s. Advanced Therapeutics Prtivate Limited, Plot #1, 2nd

M/s. Kaneka Corporation, 2-4-3-Chome, Nakanoshima,

1. Throumbuster II2. Fortis II (Balloon

Catheter)

31-187-MD/2006-DC (Re-Reg. 2011)

MD-187 28-02-2014

14

Floor, LSC New Rajinder Nagar, New Delhi-110060

Kita-ku, Osaka 530-8288, Japan having factory premises at M/s. Kaneka medix Corporation, kanagawa Plant, 225-1, Aza Deguchi, Yamakita, yamakita-Machi-Ashigara-Kami-Gun, Kanagawa, 258-0113, Japan

3. Crusade KMF0114A4. Ichiban-Yari 380-1T, 380-

3T

58. M/s. TotipotentSC Scientific Product Private Limited, No. Y-23, 3rd Street, Anna Nagar, Chennai-600040

M/s. Thermogenesis Corp., 2711 Citrus Road, Rancho Cordova, California-95742, USA

Res-Q 60 BMC 31-826-MD/2010-Dc MD-826 28-02-2014

59. M/s. Teleflex medical Private Limited, No. 19, Harrington Road, Chetpet, Chennai-600031

M/s. Willy Rusch GmbH, Willy-Rusch-Strasse 4-10, 71394 Kernen, Germany

1. Tiemann Catheter2. Deleforsse Catheter3. Embolectomy Catheter4. Silkolatex T-Tube

31-776-MD/2010-DC MD-776 28-02-2014

60. M/s. Yogi Kirpa Medi-Chem Private Limited, Amar Building, 355,56, Central Avenue Road, Chembur, Mumbai-400071

M/s. Heraeus Medical GmbH, Philipp-Reis-Str. 8/13, 61273 Wehrheim, Germany

1. Bone Cement2. Bone cement with

Gentamycin

31-376-MD/2007-DC (Re-Reg. 2010)

MD-376 31-03-2014

61. M/s India Medtronic Pvt. Ltd., 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Anheri-Ghatkopar Link Road, Andheri (E), Mumbai- 400093

M/s Medtronic Inc., 710 Medtronic Parkway N. E. Minneapolis MN 55432 USA having manufacturing premises at M/s Medtronic Mexico S. de R.L de C.V. Avenida paseo del Cucapah

1. Sprinter rapid Exchange Balloon Dilatation Catheter

2. Sprinter legent RX Balloon Dilatation Catheter

3. Melody Transcatheter Pulmonary Valve

31-381-MD/2007-DC (Re-Reg. 2010)

MD-381 14-02-2014

15

10510, Parque Industrial EI Lago, Tijuana, B.C. 22570< Mexico

62. M/s. Nobel Biocare India Private Limited, 103AB, 1?f, Fortune 2000 bandra-Kurla Complex, bandra (E), Mumbai-400051

M/s. Nobel Biocare USA LLC 22715 Savi Rusch Parkway Yorba Linda, CA 92887

Total 6 Products 31-218-MD/2007-DC (Re-Reg. 20100

MD-218 28-02-2014

63 M/s India Medtronic Pvt. Ltd., 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E), Mumbai- 400093

M/s Medtronic Inc., 710 Medtronic Parkway N. E. Minneapolis MN 55432 USA having manufacturing premises at M/s Medtronic Ireland Parkmore Business Park West Galway, Ireland

Complete SE lilac Stent System 31-64-MD/2006-DC (Re-reg. 2009) End 4

MD-64 31-07-2012

64. M/s. Faith Biotech Private Limited, E-107, Lajpat Nagar,-1, New Delhi-110024

M/s. Micro Vention Inc, 1311 Valencia Avenue, Tustin, CA, USA 92780

1. Microplex Coil System (MCS)

2. Hydro Coil Embolic System (HES)

31-804 (A)-MD/2010-DC

MD-804(A)

14-03-2014

65. M/s. baxter India Private Limited, 2nd Floor, Tower C, Building 8, DLF Cyber City, DLF Phase-II, Gurgaon-122002

M/s. Baxter Healthcare Corporation, 21026, Alexander Court, Hayward, CA 94545, USA

Total 2 products 31-686(B)-MD/2009-DC (Re-Reg. 2010)

MD-686(B)

14-03-2014

66. M/s. Lifetech Scientific India Private Limited, #3, 1st Main, 3rd Floor, BDA Layout, Kodihally, HAL 2nd Stage, Bangalore-560008

M/s. Lifetech Scientific (Shenzhen) Co. Limited, Floor 3-1 Cybio Electronic Building, Langshan 2nd Street, North Area of

Total 4 Products 31-834-MD/2010-DC MD-834 14-03-2014

16

High-Tech Park, nanshan District, Shenzhen, 518057, China

67. M/s. Johnson & Johnson Limited, 30, Forjett Street, Mumbai-400036

M/s. Ethicon Inc, Route 22 West Somercille New Jersy 08876, USA having factory premises at M/s. Ethicon Inc, 655 Ethicon Circle, Cornelia, Georgia 30531, USA

Proceed Surgical Mesh 31-827-MD/2010-DC MD-827 14-03-2014

68. M/s. Zimmer India Private Limited, Plot No. B & B1, Vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016

M/s. Zimmer GmbH Sulzer Allee 8, CH 8404 Winterthur, Switzerland

1. Metasul Taper Liner2. Biolox Delta Taper Liner

31-171-MD/2006-DC (Re-Reg. 2009) End 01

MD-171 31-07-2012

69. M/s. Ophtho Equip Inc, 703, Samrueddhi, Opp. Sakar-III, Nacrangpura, Ahmedabad-380014

M/s. Staar Surgical Co. 1911 Walker Avenue, Monrovia, CA 91016, USA having factory premises at M/s. Staar Surgical AG, Hauptsrasse 104, 2560 Nidau, Switzerland

STAAR PHAKIC IOL-CollamerImplantable Contact Lens (ICL/TICL)

31-926-MD/2011-DC MD-926 14-03-2014

70. M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E), Mumbai-400093

M/s. Medtronic Sofamore Danek Inc, 1800 Pyramid Place, Memphis, TN 38132, USA having factory premises at M/s. Medtronic Sofamor Danek Deggendorf GmbH, Werftstr 17, 94469 Deggendorf,

VERTE STACK-Spinal System(a) Capstone Vertebral Body

Spacer(b) Cornerstone PSR Peek

Implants

31-69A-MD/2006-DC (Re-Reg. 2009)

MD-69A 14-03-2014

17

Germany71. M/s. Teleflex Medical

Private Limited, 64, Rukmani Lakshmipathi Salai, (20 Marshalls Road), Egmore, Chennai-600008

M/s. Arrow International Inc, 2400 Bern Ville Road reading Pennsylvanta 19605, USA having factory premises at M/s. Arrow International Inc (Subsidiary of Arrow International inc) 9 Plymouth Street Everett, Massachusetts 02149, USA

Intra Aortic Balloon (IAB) Catheters, Sterile

31-841-MD/2010-Dc MD-841 14-03-2014

72. M/s. MN Solutions, #26 & 27, 2nd Floor, WZ-26, Nangli Jalib, B-1, Janak Puri, New Delhi-110058

M/s. Tecres SpA, Via Andrea Doria 6 37066 Sommacampagna-VR-Italy

1. Cemex2. Cemex Genta3. Spacer4. Spacer5. Mendec

31-818-MD/2010-Dc MD-818 14-03-2014

73. M/s. Nobel Biocare India Private Limited, 103AB, 1/F, Fortune 2000, Bandra-Kurla Complex, bandra (E), Mumbai-400051

M/s. Nobel Biocare AB, P.O. Box No. 5190, SE-40226, Goreborg, Sweden having factory premises at M/s. Nobel Biocare AB, Dimbovagen 2, SE-691 51 Karlskoga, Sweden

Dental Implants1. Nobel Active (Titanium)2. Branemark System

(Titanium)3. Zygoma (Titanium)4. Nobel Replace (Titanium)5. Nobel Speedy (Titanium)6. Nobel Esthetics

(Titanium)7. Procera

31-217-MD/2007-DC (Re-Reg)

MD-217 31-03-2014

74. M/s. Hemant Surgical Industries Limited, 647, Avijah Building, Ground Floor, No. 6 & 7, Girgaum Road, Mumbai-400002

M/s. Shanghai Kindly Enterprise Developmetn Group Co. Limited, No. 18 Lan,e 668 Haujiang Road, 201803, Shanghai, China

1. Scalp Vein Set2. Hypodermic Needles3. Syringes

31-854-MD/2010-Dc MD-854 14-03-2014

75. M/s. Covidien Healthcare India

M/s. Sofradim Production 116

a. Parietexb. Parietex Composite

31-933-MD/2011-Dc MD-933 14-03-2014

18

Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010

Avenue du Formans F-01600 Trevoux, Frnace

c. Parietene d. Parietene Composite

76. M/s. Kalyx India Healthcare Private Limited, No. 21, ‘F’ Block, Anna Nagar East, Chennai-600102

M/s. AAP Implantate AG, Lorenzweg 5 D-12099 Berlin, Germany

Medical Device Family: Bone Plates, Bone Screws & Wire, Bone Kit

31-835-MD/2010-DC MD-835 31-03-2014

77. M/s. Boston Scientific International BV, 100A, The Capital Court, Olof Plame, Marg, Munirka, New Delhi-110067

M/s. Boston Scientific Corporation, Boston Scientific Palace, Natick, Massachusetts 01760-1537, USA

Wingspan Stent System 31-165-MD/2006-DC MD-165 14-06-2013

78. M/s. Alcon Laboratories India Private Limited, Unit No. 502, Tower “D”, 5th

Floor, RMZ Infinity, benniganahalli, Old Madras Road, Bangalore-560016

M/s. Alcon Research Limited, 714 Columbia Avenue, Sinking Spring, Pennsyllvania, 19608, USA

Alcon Non-Absorbable Surgical Suture

31-875-MD/2010-Dc MD-875 31-03-2014

79. M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building Number 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E), Mumbai-400093

M/s. Medtronic Ireland, parkmore Business park, West Galway, Ireland having factory premises at M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN-55432, USA

Raliant Stent Graft Balloon Catheter

31-64-MD/2006-DC (Re-Reg. 2009) End 07

MD-64 31-07-2012

80. M/s. MN Solutions, #26 & 27, 2nd Floor, WZ-26, Nangli Jalib, B-1, Janak Puri, New Delhi-110058

M/s. Biomatlante, 5 rue Edouard belin, ZA Les Quatre nations, 44360, Vigneux de Bretagne, France

Bone X (Calcium Phosphate Bone Substitute)

31-800-MD/2010-DC MD-800 31-03-2014

81. M/s. Covidien M/s. Covidien IIc, 15 1. Endobronchial Tubes 31-419-MD/2008-DC MD-419 14-04-2014

19

Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010

Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. Mallinckrodt Medical, Commaddy, Athlone Co. Westmeath, Ireland

2. Tracheal Tubes3. Tracheostomy Tubes

(Re-Reg. 2011)

82. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, Distt-Thane, Bhiwandi

M/s. Cordis Cashel, Cahir Road, Cashel Co. Tipperary Ireland having factory premises at M/s. Cordis de Mexico SA, de CV Calle Circuito Interior Norte # 1820, Parque Industrial Salvarcar, Ciudad Juarez, Chihuahua, mexico 32575

Total 13 products 31-881-MD/2010-DC MD-881 14-04-2014

83. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010

M/s. Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. Mallinckrodt DAR, via G Bove 2/4/6/8, 41037, Mirandola (MO), Italy

Closed Sunction System with accessories (Replaceable catheter, Pediatric, Neonatal)

31-418-MD/2008-DC (Re-Reg. 2011)

MD-418 31-03-2014


M/s. Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. Covidien, 5439 State Route 40 Argyle, NY 12809, USA

Total 9 products 31-50-MD/2006-DC (Re-Reg. 2011)

MD-50 31-03-2014

85. M/s. Covidien Healthcare India

M/s. Kendall Kenmex, A Division of Tyco

1. Trocar Catheters2. Thoracic Catheters

31-47-MD/2006-DC (Re-Reg. 2011)

MD-47 31-03-2014

20

Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010

Healthcare Group LP, 15 Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. Tyco Healthcare Group LP, Calle 9 Sur No. 125, Ciudad Industrial Tijuana, Mexico CP 22500


M/s. Kendall, A Division of Tyco Healthcare Group LP, 15 Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. nellcor Puritan Bennett Mexico SA de CV, 37 blvd, Insurgentes, Libramiento a la P, La Mesa, Tijuana, BC, Mexico

1. 100% Silicone Folley catheters

2. Silison Thoracic Catheter

31-49-MD/2006-DC (Re-Reg. 2011)

MD-49 31-03-2014

87. M/s. MIV Therapeutics India Private Limited, 136-B, Surat Special Economic Zone, Road No. 4, Diamond Park, GIDC, Sachin, Surat-394230

M/s. Natec Medical Limited, maeva Centre, Business park, Ebene, Reduit, Mauritius

1. Tamarin Blue (Non-Sterile) PTCA Catheter

2. Filao Rx (Non Sterile) PTCA Catheter

31-326-MD/2007-DC (Re-Reg. 2010)

MD-326 31-03-2014

88. M/s. Advanced Lifesciences Private Limited, D-22, Okhla Industrial Area, Phase-I, New Delhi-110020

M/s. Merit Medical Systems Inc, 1600 West Merit parkway, South Jordan, Utah 84095, USA having factory premises at M/s. Merit Medical Systems Inc, 1111

1. Diagnostic Angiographic Catheters-Performa

2. Diagnostic Angiographic Catheters-Softuch

3. Diagnostic Angiographic Catheters-Impress

4. Guide Catheters-Concierge

31-158-MD/2006-DC (Re-Reg. 2009)

MD-158 31-03-2014

21

South Velasco, Angleton, Texas 77515, USA

89. M/s. Advanced Lifesciences Private Limited, D-22, Okhla Industrial Area, Phase-I, New Delhi-110020

M/s. Merit Medical Systems Inc, 1600 West Merit parkway, South Jordan, Utah 84095, USA

1. Infusion Catheters-Fountain

2. Infusion Catheters-Mistique

31-937-MD/2011-Dc MD-937 31-03-2014

90. M/s. Teleflex medical Private Limited, Old No. 10, No. 19, Harrington Road, Chetpet, Chennai-600031

M/s. Arrow International Inc, 2400 Bern Ville Road, Reading Pennsylyania 19605, USA having factory premises at M/s. Arrow International inc, 312 Commerce Palace, Asheboro, North Carolina 27203, USA

Total 8 products 31-844-MD/2010-Dc MD-844 31-03-2014


M/s. ev3 Inc, 4600 Nathan Lane North, Plymouth, MN 55442, USA

1. Protégé2. ParaMount Mini GPS

Stent System3. SpideFx4. Goose Neck Snare

catheters5. VisiPro Balloon

Expandable Biliary Stent System

6. NanoCross .014 OTW PTA Dialation Catheter

7. EverCross .035” OTW PTA Dialation catheter

31-51-MD/2006-DC (Re-Reg. 2011)

MD-51 31-03-2014

92. M/s. Covidien Healthcare India Private Limited, “Doshi Towers”, 6th Floor, #156, Poonamallee High Road, Kilpauk,

M/s. ev3 Inc, 4600 Nathan Lane North, Plymouth, MN 55442, USA having factory premises at M/s. Micro Therapeutics Inc, d/b/a

SilverHawk Peripheral Plaque Excision

31-624-MD/2009-DC (Re-Reg. 2011)

MD-624 31-03-2014

22

Chennai-600010 ev3 Neurovascular Inc, 9775 Toledo Way, Irvine, CA 92618, USA

93. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, Dist-Thane, Bhiwandi

M/s. Biosense Webster Inc, 3333 Diamond Canyon Road, Diamond Bar, CA 91765, USA having factory premises at M/s. Siemens Limited, Seoul, Pohang Technopark, 601, Jigok dong, Nam-gu, Pohang-si, 2nd & 3rd venture Blvd, Gyeongsangbuk-do 790-834, Republic of Korea

SoundStar 3D Diagnostic Ultrasound Catheter

31-898-MD/2010-Dc MD-898 14-04-2014

94. M/s. Abbott Medical Optics Private Limited, No. 91, G N T Road, Madhavraman, Chennai-600110

M/s. Abbott Medical Optics Inc, 1700 E. St. Andrew Place Santa Ana, California 92705, USA having factory premises at M/s. AMO Groningen BV, Van Swietenlaan 5, 9728 NX Groningen, The Netherlands

Tecnis Multifocal 1-Piece Intraocular Lens (Model: ZMB00)

31-17-MD/2006-DC (Re-reg.) End 01

MD-17 31-05-2013

95. M/s. Cure Surgicals, S-12, 1st Floor, Green park Extension, Opp. Uphaar Cinema, New Delhi-110016

M/s. Biosomposites Limited, Keele Science Park, Keele Newcastle Under Lyme, Staffordshire, STS 5 NL, England

1. Genex-Bone void filler/Bone Graft Substitute

2. Stimulan-Bone void filler/Bone Graft Substitute

3. Allogran-R-Bone void filler/Bone Graft Substitute

4. Allogran-N-Bone void

31-402-MD/2007-DC (Re-reg. 2011)

MD-402 30-06-2014

23

filler/Bone Graft Substitute

96. M/s. Clairvoyance Consulting, Flat No. 801, 8th Floor, Indra Prakash Building, 21, Barakhamba Road, Connaught Place, New Delhi-110001

M/s. Invatec Technology Centre GmbH, Hungerbuelstrasse 12a, 8500 Frauenfeld, Switzerland

IN.PACT Falcon (Rx & OTW)-Paclitaxel-eluting Balloon Dilatation PTCA Catheter

31-833-MD/2010-Dc MD-833 31-03-2014

97. M/s. Cure Surgicals, S-12, 1st Floor, Green park Extension, New Delhi-110016

M/s. Synergie Ingenierie Medicals-S.A.R.L., Z.A. de L’Angle 19370 Chamberet-France

1. Bio Fix Spacer2. Bio Fix (VTP, 3, 3G, 1, 1G,

PR, PR3G & Carnioplasty)

31-666-MD/2009-DC MD-666 14-04-2014


M/s. Covidien IIc, 15, Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. Covidien Zona Frnaca de san Isidro, Santo Domingo, Dominican Republic

1. Ticron2. Polysorb Lactometer3. Steel 316L Stainless Steel

Suture4. Flexon temporary Cardiac

Pacing Lead

31-948-MD/2011-DC MD-948 14-04-2014


M/s. Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048, USA having factory premises at M/s. Covidien 60, Middletown, Avenue, North Haven, CT 06473, USA

Total 9 products 31-949-MD/2011-DC MD-949 14-04-2014

100. M/s. Abbott Healthcare Private Limited, 4, Corporate Park, Sion Trombay Road, Chembur, Mumbai-400071

M/s. Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA having factory premises at M/s. Abbott Vascular,

NC TREK Coronary Dilatation Catheter Product Family (NC TREK RX)

31-307-MD/2007-DC (Re-Reg. 2010) (End 01)

31-307 30-06-2013

24

26531 Yenz Road, Temecula, California 92591, USA

101. M/s. Abbott Healthcare Private Limited, 4, Corporate Park, Sion Trombay Road, Chembur, Mumbai-400071

M/s. Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA having factory premises at M/s. Abbott Vascular, 26531 Yenz Road, Temecula, California 92591, USA

Absolute PRO peripheral Self-Expanding Stent System Family

31-256A-MD/2006-DC (Re-Reg. 2010) (End 01)

MD-256A 30-04-2013

102. M/s. Hansraj Nayyar Medical, 1416 Maker Chambers V, 14th Floor, Nariman Point, Mumbai-400021

M/s. Smiths Medical ASD Inc, 10, Bowman Drive, Keene, NH 03431 0724, USA having factory premises at M/s. Smiths Medical International Limites, St. Crisping Way, Haslingden, Rossendale, Lancashire, BB4 4PW, UK

Epidural Catheter 31-830-MD/2010-DC MD-830 14-04-2014


M/s. Ethicon sarl, Puits Godet 20, 2000 Neuchatel, Switzerland

1. Gynecare TVT Exact Continence System

2. Gynecare TVT ABBREVO Continence System

3. Gynecare PROSIMA Pelvic Floor Repair System

31-845-MD/2010-DC MD-845 31-04-2014


M/s. Mentor Medical Systems B.V., Zernikedreef 2, 2333 CL Leiden, The Netherlands

1. Gel Breast Implant-Cohesive I, II, III Smooth/Siltex./CPG

2. Becker Expanders/Breast Implants

3. Spectra Adjustable Gel Breast Implants

31-884-MD/2010-DC MD-884 30-04-2014

105 M/s. India Medtronic M/s. Medtronic Inc, Resolute Integrity Zotarolimus 3164-MD/2006-DC MD-64 31-07-2012

25

Private Limited, 1241, Solitaire Corporate Park, Building No. 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri East, Mumbai-400093

710 Medtronic Park Way, NE Minneapolis, MN-55432, USA having factory premises at M/s. Medtronic Ireland Parkmore Business Park West, Galway, Ireland

Eluting Coronary Stent System (Re-Reg. 2009) End 08

106 M/s. Boston Scientific International BV, C-40, Okhla Industrial Area, Phase-II, New Delhi-110020

M/s. Boston Scientific Corporation, One Boston Scientific Place, Natick Massachusetts 01760-1537, USA having factory premises at M/s. Boston Scientific Cork Limited, Business & Technology Park, Model Farm Road, Cork, Ireland

1. Neuroform EZ Stent Delivery System

2. Neuro Renegade Hi-Flo Microcatheter

31-163-MD/2006-DC (Re-Reg. 2009) (End 01)

MD-163 31-03-2013

107 M/s. Smith & Nephew Healthcare Private Limited, Building 2-3 & 15-17 Rahlaxmi Complex, Opp. Hanuman Bus Stop, Kalher, Thane-Bhiwandi Road, Thane-421302

M/s. Smith & Nephew Inc, 1450, Brooks Road, Memphis Tennessee 38116, USA having factory premises at M/s. Smith & Nephew Orthopaedics GmbH, Alemannenstrasse 14, Tuttlingen, Germany

CPCS Hip[ System 31-858-MD/2010-Dc MD-858 14-04-2013

108 M/s. Avana Medical Devices Private Limited, 2nd Floor, N6D.O. 14.D, Viswanathan Street, West Mambalam, Chennai-600033

M/s. Arthrex Inc, 1370 Creekside Boulevard, Naples, Florida, USA 34108-1945

Total 4 drugs 31-846-MD/2010-DC MD-846 14-04-2014

109 M/s. Teleflex Medial M/s. Arrow 1. Central Venous Catheter 31-842-MD/2010-DC MD-=842 14-04-2014

26

private Limited, Old No. 19, 1st Floor, & Ground Floor, Harrington Road, Chetpet, Chennai-600031

International Inc, 2400 Bern Ville Road, Rading Pennsylkvania 19605, USA having factory premises at M/s. Arrow International de Chihuahua S.A. de C.V. Modulo1, Circuito 5, Parque Industrias de America Col. Panamericana, Chihuahua 31200 Mexico

2. Arterial Catheters and Accessories, Sterile

3. Percutaneous Sheath Introducers and accessories sterile

4. Spring wire guide and accessories, sterile

110 M/s. Biotronik Medical devices India Private Limited, 101-106, Plot No. 14, LSC, Kalkaji, New Delhi-110019

M/s. Biotronik AG, Ackerstasse 6, 8180 Bulach, Switzerland

Total 8 drugs 31-461-MD/2008-DC (Re-Reg. 2010)

MD-461 30-04-2014


M/s. Ethicon LLC, 475 C Street, Los Frailes Industrial Park, Suite 401, Guaynabo 00969, Puerto Rico, USA having factory premises at M/s. Ethicon Inc, Calle Durango No. 2751 Lote Bravo, Ciudad Juarez, Chihuahua, C. P. 32575, Mexico

Total 13 drugs 31-798(A)-MD/2010-DC

MD-798(A)

30-04-2014

112. M/s. 3M India Limited, Plot Nos 48-51, Electronic City, Hosur Road, Bangalore-560100

M/s. 3M Healthcare Care, St. paul, MN 55144-1000, USA having factory premises at M/s. 3M Deutschland GmbH/Medical

1. 3M Tegaderm IV Transparent Film Dressing with Border

2. 3M Tegaderm IV Transparent Film Dressing with Frame Style

31-710 (C )-MD/2009-DC

MD-710 (C )

30-04-2014

27

manufacturing Kamen, Edisonstrasse 6, Kamen, Germany 59157

113. M/s. Covidien Healthcare India Private Limited, Doshi Towers, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010

M/s. Covidien Inc, 15 Hampshire Street, Mansfield MA 02048, USA having factory premises at M/s. Covidien Building 911-67 Sabanetas Industrial Park, Ponce, Puerto Rico 00731, USA

Helical Fasteners 31-796-MD/2010-DC (Re-Reg. 2011)

MD-796 30-04-2014

114. M/s. Covidien Healthcare India Private Limited, Doshi Towers, 6th Floor, #156, Poonamallee High Road, Kilpauk, Chennai-600010

M/s. Tyco Healthcare Ireland Limited, Sragh Industrial Estate, Tullamore County, Ofally, Republic of Irlenad

1. Trocar Catheters2. Thoracic Catheters

31-46-MD/2006-DC (Re-Reg. 2011)

MD-46 30-04-2014

115. M/s. Teleflex Medial private Limited, Old No. 19, 1st Floor, & Ground Floor, Harrington Road, Chetpet, Chennai-600031

M/s. Willy Rusch GmbH, Willy-Rusch-Strasse 4-10, 71394, Kernen, Germany

RUSCH, ENDO TRACHEAL TUBES 31-776-MD/2010-DC (End 01)

MD-776 28-02-2014

116. M/s. becton Dickinson India private Limited, 5th Floor, Signature Towers, II, South City 1, Gurgaon-122001

M/s. Becton Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, USA having factory premises at M/s. BD Medical Surgical, 1852, 10th Avenue, Columbus, NE 68601, USA

1. BD Blunt Fill Needles2. BD Blunt Fill Needles with

Filter

31-669 (B)-MD/2009-DC (End 01)

MD-699(B)

14-01-2013

28

117. M/s. Globe Biomedicals, Room C/2, Juhu Apartment, Near S.N.D.T. College , Juhu, Mumbai 400049, Maharashtra

M/s. Dongguan Kewei Medical Instruments Co. Limited, Shijing Industrial Zone, Tongsha Technology Park, Dongcheng District, Dongguan City, Guangdong Province, China

1. Amender ASD Occluders2. Amender PDA Occluders3. Amender VSD Occluders

31-821-MD/2010-DC MD-821 14-05-2014


M/s. Micro Therapeutics Inc, d/b/a ev3 Neurovascular, 9775 Toledo Way, Irvine, CA 92618, USA

Total 12 Drugs 31-51A-MD/2006-DC (Re-Reg. 2011)

MD-51A 14-05-2014

119. M/s. becton Dickinson India Private Limited, No. 34, Assisi Nagar, West Thottam, Madhavaram, Chennai-51

M/s. Becton Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, USA having factory premises at M/s. BD Caribe Limited, Road 31 KM 24.3 PO Box 4010, Juncos, Puerto Rico 00777-4010, USA

1. Kit VECSE 27G Whitacre/ 18G Weiss

2. Kit Perisafe 18G x 3/12” Weiss

31-819-MD/2010-DC MD-819 14-05-2014


M/s. Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048, USA

1. Palindrome H Chronic Catheter Kit

2. Palindrome SI Chronic Catheter Kit

3. Palindrome HIS Chronic Catheter Kit

31-50-MD/2006-DC (Re-Reg. 2010) End 01

MD-50 31-03-2014

121. M/s. Smart Ortho Devices Private Limited, #3, Park View-I, Sohna Road, Gurgaon

M/s. ABS Corporation Inc, 5909 Baker Road, Suite 550, Minnetonka, MN 55345, USA

OrthoGlide Medical Knee Implant 31-902-MD/2011-DC MD-920 14-05-2014

29


M/s. Mediquip Sdn. Bhd, PO Box 25, 01700 Kangar, Perlis, Malaysia

Kendall Curity Latex Foley Catheter (Indwelling Urinary Catheter)

31-333-MD/2007-DC (Re-Reg. 2011)

MD-333 31-05-2014

123. M/s. India Medtronic Private Limited, 1241, Solitaire Corporate Park, Building No. 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E), Mumbai-400093

M/s. Medtronic Sofamore Denek inc, 1800 Pyramid Place Memphis TN 38132, USA having factory premises at M/s. Medtronic Sofamore Danek, Deggendorf, Werfstr 17, 94469, Deggendorf, Germany

1. PEEK Prevail Cervical Interbody Device

2. CLYDESDALE Spinal System

31-69A-MD/2006-DC (Re-Reg. 2009) End 01

MD-69A 14-03-2014


M/s. Medtronic Sofamore Denek inc, 1800 Pyramid Place Memphis TN 38132, USA having factory premises at M/s. Medtronic Sofamore Danek, Deggendorf, Werfstr 17, 94469, Deggendorf, Germany

Mastergraft Granules 31-69A-MD/2006-DC (Re-Reg. 2009) End 02

MD-69A 14-03-2014

125. M/s. KOB Medical textiles Private Limited, 9. Manirajanna Gardens, D. No. 1996-C, Trichy Road, Singanallur, Coimbatore-641005

M/s. Karl Otto Braun GmbH & Co., KG, Lauterstrasse 50, 67752, Wolfstein, Germany

1. Kobra Cast-Thermoplastic Cast Bandage

2. Rinkilastic Cohesive-Cohesive Elastic Bandage

3. Rapidelast Color-Cohesive Elastic bandage

31-920-MD/2011-DC MD-920 31-05-2014

126. M/s. St. Jude medical India private Limited, A & B, 2nd Floor, “Brij Tarang”, Greenlands,

M/s. Light Lab Imaging Inc, One technology Park Drive, Westford, MA 01886, USA

C7 Dragonfly Imaging Catheter 31-896-MD/2010-DC MD-896 31-05-2014

30

Begumpet, Hyderabad-500016

127. M/s. Bioaide technologies Private Limited, 207, Savitri Cinema Complex, Greater kailash II, New Delhi

M/s. Lohmann and Rauscher International GmbH & Co., Kg, Westerwaldstrasse 4. 56579 Rengsdorf, Germany

1. Curapor (Sterile Island Dressing)

2. VIiwazell (Sterile Dressing Pad)

3. Metalline (Sterile Dressing Pad)

4. Raucodrape Surgical Incise Drape

31-490-MD/2008-DC (Re-Reg. 2011)

MD-490 30-06-2014


M/s. Ethicon Sarl, Puits Godet 20, 2000 Neuchatel, Switzerland

Total 6 drugs 31-845-MD/2010-DC (End 01)

MD-845 30-04-2014

129. M/s. DePuy medical private Limited, Plot no. 4, Survey No. 277/4, Demni Road, Village-Dadra-Dadra & Nagar haveli (U.T.)

M/s. DePuy International Limited, trading as M/s. DePuy CMW, Cornford Road, Blackpool, FY4 4QQ, England UK

Total 7 drugs 31-915-MD/2011-DC MD-915 31-05-2014

130. M/s. Terumo Corporation, Chennai Branch, Alexander Square, 34 & 35, 4th Floor, Sardar Patel Road, Guindy, Chennai-600032

M/s. Vascutek limited, A Terumo Company, Newmains Avenue, Inchinnan, Renfrewshire, PA4 9RR, Scotland

Total 6 drugs 31-880-MD/2010-Dc MD-880 14-06-2014

131. M/s. Spinemed Systems, LG-1, Pankaj Market, Behind Natraj Vihar Society, I.P. Extn. Patparganj, Delhi-110092

M/s. Orthofix Inc, 3451, Plano Parkway, Lewisville, Tx 75056

1. Spinal Fixation System2. Ascent TM POCT System3. Firebird Spinal Fixation

System4. 3 Deg Anterior Cervical

Plate System5. Pillar Peek Spacer System6. Construx Peek Partial

VBR System

31-976-MD/2011-DC MD-976 31-05-2014

31

132. M/s. Hester Diagnostics Private Limited, Room No. 9, 1st Floor, 66, princess Street, Mumbai-400002

M/s. Penumbra Inc, 1351, Harbor Bay, Parkway, Alameda, CA 94502, USA

Penumbra System consisting of:1. Penumbra Reperfusion

Catheter 2. Penumbra Separator3. Penumbra Aspiration

Tubing4. Neuron delivery Catheter5. Neuron Select Catheter

31-499-MD/2008-DC (Re-Reg. 2011)

MD-499 30-09-2014

133. M/s. Smith & nephew Healthcare Private Limited, C/o Shebros Agencies, Minakshi Industrial estate, Gala -1, Building-1, Naikpada, W.E. Highway, Vasai (E), Maharashtra-410208

M/s. Smith & Nephew Medical Limited, 101 Hessle Road, Hull, HU3 2BN, UK

Acticoat/Acticoat7 31-969 (FF-159)-MD/2011-DC

MD-969 (FF-159)

30-04-2012

134. M/s. St. Jude medical India private Limited, A & B, 2nd Floor, “Brij Tarang”, Greenlands, Begumpet, Hyderabad-500016

M/s. St. Jude Medical System AB, Palmbladsgatan 10, Box 6350 SE 75135 Uppsala, Sweden

1. PressureWire Aeris Including PressureWire Receiver

2. PressureWire Certus

31-727-MD/2009-DC MD-727 14-07-2014

135. M/s. DePuy Medical Private Limited, 64-66 Senapati Bapat Marg, Mahim, Mumbai-400016

M/s. DePuy Spine, Inc, 325 Paramount Drive, Raynham, Massachusetts 02767, USA having factory premises at M/s. DePuy Inc, 50 Scotland Park Drive, Bridgewater, Massachusetts 02324, USA

Moss Miami Spinal System (Non-Sterile)

31-288-MD/2006-DC (Re-Reg. 2010) End 01

MD-288 14-06-2013


M/s. Clearstream Technologies Limited, Moyne Upper, Enniscorthy Co.

Sleek PTW PTA balloon Catheter (Sterile)

31-239-MD/2006-D (Re-Reg. 2009) (End 01)

MD-239 31-12-2012

32

Wexford, Ireland137. M/s. Abbott Healthcare

Private Limited, 4, Corporate Park, Sion Trombay Road, Mumbai-400071

M/s. Abbott Laboratories, Abbott Vascular Inc, 400 Saginaw Drive, redwood City, California 94063, USA

1. Prostar XL Percutaneous Vascular Surgical System and Accessories

2. Perclose ProGlide Suture-Medicated Closure System and Accessories

31-867-MD/2010-DC MD-867 30-06-2014

138. M/s. Johnson and Johnson Limited, J-1 Shree Arihant Complex, Vill Kalher, Thane-Bhiwandi Road, Dist-Thane, Bhiwandi

M/s. Johnson & Johnson Wound Management, a division of M/.s. Ethicon Inc, Route 22 West Somerville, new Jersy 08876-0151, USA having factory premises at M/s. Integra neuroscience PR Inc, State Road 402, Anasco, PR 00610, Puerto Rico, USA

Biopatch Antimicrobial Dressing with Chlorhexidine Gluconate

31-815(B) (FF-325)-MD/2008-DC (Re-Reg. 2010)

MD-815(B)

14-07-2014


M/s. VNUS medical technologies Inc, 5799 Fontanoso Way, San Jose CA 95138, USA

Catheter (Closure Fast Closure RFS)

31-789-MD/2010-DC MD-789 14-07-2014

140. M/s. Zimmer India Private Limited, Plot No. B & B1, vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016

M/s. Zimmer Inc, 1800 West centre Street, Warwaw, Indiana 46580, USA

Cable Ready Cable Grip System 31-170-MD/2006-DC (Re-Reg. 2009) End 03

MD-170 31-07-2012

141. M/s. becton Dickinson India Private Limited, No. 34 Assisi Nagar, West Thottam,

M/s. Becton Dickinson Infusion Therapy AB, Gasebacksvagen 36, PO Box 631, 251 06

BD Connecta 31-911-MD/2011-DC MD-911 30-06-2014

33

Madhavaram,. Chennai-51

Helsinborg, Sweden having factory premises at M/s. becton Dickinson Infusion Therapy Systems Inc, SA de C.V. 579 Periferico Luis Donaldo Colosio, Colonia Obrera in Nogales Sonora 84048, mexico

142. M/s. Biomet Orthopaedic India Private Limited, 2301, Shanti Esate, Ghansham Estate, National Highway No. 8, Aslali, Tal: Daskroi (NA)

M/s. Biomet 3i, 4555 Riverside Drive, palm beach Gardens, Florida 33410, USA

Dental Implant System 31-900-MD/2010-DC MD-900 30-06-2014

143. M/s. Exactech India Private Limited, No. 21, ‘F’ Block, 2nd Floor, Annanagar east, Chennai-600102

M/s. Exactech Inc, 2320, 2243, 2402 & 2411, NW 66th Court, Gainesville, Florida 32653, USA

1. Total Hip Replacement System-cemented

2. Total Hip Replacement System-Cementless

3. Total Knee Replacement System

4. Exactech Equinoxe Shoulder System

31-503-MD/2008-DC (Re-Reg. 2011)

MD-503 31-07-2014

144. M/s. Biotronik medical devices India Private Limited, 101-106, Plot No. 14, LSC, Kalkaji, New Delhi-110019

M/s. Biotronik AG, Ackerstasse 6, 8180 Bulach, Switzerland

Pantera Lux Paclitaxel Releasing PTCA Balloon Catheter

31-461-MD/2006-DC (Re-Reg. 2010) End 01

MD-461 30-04-2014

145. M/s. Cosmotec Medicaments Private Limited, No. 2, 1st Floor, HR-8, Balaji Complex, Sharma Market, Pulpehladpur,

M/s. Mondeal Medical System GmbH, Gewerbering 7, 78570 Muhlheim an der Danau, Germany

Orthopaedic Implants (Non-Sterile)Mondeal Titanium Orthopaedic Implants (Plates, Screws, Pins, Mesh)

31-814(A)-MD/2010-DC

MD-814 (A)

14-06-2014

34

New delhi-110044146. M/s. Baxter India

private Limited, 2nd Floor, Towe C, Building 8, DLF Cyber City, Phase-II, Gurgaon-122002

M/s. baxter Healthcare Croporation, 21026, Alexander Court, Hayward, CA 94545, USA

Floseal Special Applicator Tips 31-734(A)-MD/2009-DC (Re-Reg. 2011) End 01

MD-374(A)

14-01-2014

147. M/s. Vascular Solutions India private Limited, Building No. H-142, 1st Floor, Rajlaxmi Commercial Complex, Kalher, Thane-Bhiwandi Road, Bhiwandi-421302

M/s. Clearstream Technologies Moyne Upper, Enniscorthy, Co. Waxford, Ireland

1. Nimbus Salvo PTCA Catheters

2. EzeCTO PTCA Catheters3. EzeCTO-RX PTCA

Catheters4. FlexeCTO PTCA Catheters

31-231-MD/2006-DC (Re-Reg. 2010) End 01

MD-231 14-06-2013


M/s. Zimmer GmbH, Sulzer Allee 8, CH-8404 Winterthur, Switzerland

1. Ceramic Femoral Head2. Metal (CoCr) Femoral

Head3. Metasul Head

31-171-MD/2006-DC (Re-reg. 2009)End 05

MD-171 31-07-2012

149. M/s. Clairvoyance Consulting, Flat No. 801, 8th Floor, Indra Prakash Building, 21 Barakhamba Road, Connaught Place, New Delhi-110001

M/s. Invatec Technology centre GmbH, Hungerbuelstrasse 12a, 8500 Frauenfeld, Switzerland

Maris Plus-Peripheral Self-Expanding Stent System

31-833-MD/2010-DC (End 02)

MD-833 31-03-2014

150. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, District-Thane, Bhiwandi

M/s. Ethicon Inc, Route 22 West, Somerville, New Jersy 08876-0151, USA having factory premises at M/s. Ethicon Inc, 5250 Greens Dairy Road, Raleigh, North Carolina 27616, USA

Ethicon OMNEX Surgical Sealant 31-899-MD/2010-DC MD-899 30-06-2014

35

151. M/s. DePuy Medical private Limited, 64-66, Senapati Bapat Marg, Mahim, Mumbai-400016

M/s. DePuy Spine Inc, 325 Paramount Drive, Raynham, Massachusetts 02767, USA having factory premises at M/s. DePuy Inc, 50 Scotland Park Drive, Bridgewater, Massachusetts 02324, USA

1. Uniplate 2 Anterior Cervical Plate System

2. Expedium Spine System-Peek Rod

31-288-MD/2006-DC (Re-Reg. 2010) End 02

MD-288 14-06-2013

152. M/s. Atlantic Pharmaceuticals, 101, Business Point 349, Western Express Highway, Andheri (E), Mumbai-400069

M/s. Joline GmbH & Co. KG Neue Rottenbunger Str, 50-D-72379 Hechingen

1. Double Lumen ST Catheter Kit

2. Double Lumen LT Catheter Kit

31-243-MD/2006-DC (Re-Reg. 2010)

MD-243 14-07-2014

153. M/s. Anand mediproducts Private Limited, 16, Road No. 33, Punjabi Bagh Extn, New Delhi-110026

M/s. Degradable Solutions AG, Wagistrasse 23 CH-8952 Schieren, Switzerland

Easy Graft/Crystal 31-870-MD/2010-Dc MD-870 31-07-2014

154. M/s. Globe Bio-Medical, C/2 Juhu Apartments, Near S.N.D.T. College, Juhu, Mumbai-4000049

M/s. Alco-advanced Lighweight construction GmbH, Teplitzer str, 5-D, 14193, Berlin, Germany

1. Alis CR L 605 Rapamycin Eluting Coronary Stent

2. Alis 20 Coronary Stent3. Alex-R Rapamycin Eluting

PTCA Catheter4. Alex Coronary Dilation

Catheter

31-04-MD/2006-DC (Re-reg. 2009)

MD-04 30-06-2012

155. M/s. Amardeep Enterprises, No. 5-6, 3rd Floor, Nr. Income Tax Building, Ashram Road, Ahmedabad-380009

M/s. Solco Bio-Medical Co. Limited, 34-6, Keumam-ri, Seotan-myeon Pyengtack, Gyeonggi-do, 451-852, The Republic of Korea

4CIS Solar Spine System (Non-Sterile)

31-383-MD/2007-DC (Re-Reg. 2011)

MD-383 31-07-2014

156. M/s. St. Jude Medical India Private Limited, A & B, 2nd Floor, Brij

M/s. St. Jude medical cardiac Rhythm Management Division

Total 7 drugs 31-300-MD/2007-DC (Re-Reg. 2010) End 01

MD-300 14-09-2013

36

Tarang, Greenland, Begumpet, Hyderabad-500016

15900 Valley View Court Sylmar 91342, USA

157. M/s. metro Biosol Private Limited, 26 Hauz khas Vill, New Delhi-110016

M/s. VEXIM SAS, 75, rue Saint Jean, 31130, Balma, France

Spine Jack System1. Preparation Kit2. Expansion Kit3. Cohesion Bone Cement

31-924-MD/2011-DC MD-924 31-07-2014


M/s. Medtronic Inc, 710 Medtronic Park Way, NE Minneapolis, MN-=55432, USA having factory premises at M/s. Medtronic Ireland Markmore Business Park, West Galway, Ireland

Valiant Thoracic Stent Graft with the Captivia delivery System

31-64-MD/2006-DC (Re-Reg. 2009) End 09

MD-64 31-07-2012


M/s. Johnson & Johnson International, C/o European Logistics centre Lenneke Marelann 6, BE-1932 St Stevens Woluwe, Belgium having factory premises at M/s. Johnson & Johnson Medical GmbH, Robert Koch Srasse 1, D-22851 Norderstedt, germany

Physiomesh 31-816(FF-319)-MD/2008-DC (Re-Reg. 2011) End 01

MD-816 (FF-319)

14-02-2014

160. M/s. Apothecaries Private Limited, 579, devil, East of Sainik Farms, New Delhi-110062

M/s. Hoya Corporation, 2-7-5 Naka-Ochiai, Shinjuku-Ku, Tokyo 161-8525, Japan having factory premises at M/s. Hoya Medical Singapore Pte Limited, 455A, Jalan

Hoya AF-1iMics1 NY-60 31-701-MD/2009-DC (End 01)

MD-701 30-11-2012

37

Ahmad Ibrahim 639939, Singapore


M/s. Biosense Webster Inc, 3333 Diamod Canyon Road, Diamod Bar, CA 91765, USA having factory premises at M/s. Biosense Webster Inc, Circuito Interior Norte #1820, Parquw Industrial Salvacar, Juarez, Chihuahua, Mexico 32599

Webster CS Catheter 31-119-MD/2006-DC (re-reg. 2009) End 01

MD-119 31-05-2013

162. M/s. fenwal India private Limited, Khasra # 1220, 1st & 2nd Floor, Village Ritahla, Delhi-110085

M/s. Fenwal Inc, Three Corporate Drive, lake Zurich IIlinois 60047, USA having factory premise at M/s. Fenwal International Inc, Camino Real Industrial park, Road # 122, San German, Puerto Rico 00683, USA

1. Amicus Apheresis Kit2. Closed System Apheresis

Kit3. Open System Apheresis

Kit

31-963-MD/2011-DC MD-963 31-07-2014


M/s. Ethicon Inc, Route 22 West, Somerville, New Jersy 08876-0151, USA

1. Prolene Soft Mesh2. Gynecare Gynemesh PS3. Vicryl Mesh

31-906 (FF-132)-MD/2011-DC (end 01)

FF-132 28-02-2012

164. M/s. Cure Surgicals, Shop No. 4, G.F. Green Park Extn, New Delhi

M/s. GS Medical Co. Limited, 12-F, Kolon Digital Twoer Aston, 505-14, Gasan-dong, Geumcheon-gu, seoul, 153-803, Korea having factory premises at M/s. GS Medical Co. Limited, #636, Yeonje-ri, Gangoe-myeon,

GSS Pedicle Screw System 31-945-MD/2011-DC MD-945 31-07-2014

38

Cheongwon-gun, Chungbuk, Korea


M/s. Covidien IIc, 15 Hampshire Street, Mansfield MA02048, USA having factory premises at M/s. Covidien, Building 911-67, Sabanetas Industrial park, Ponce, Puerto Rico 00731, USA

Surgipro II Monofilament Polypropylene Suture

31-796-MD/2010-DC (Re-Reg. 2011) End 01

MD-796 30-04-2014

166. M/s. Boston Scientific International BV, 100A, The Capital Court, Olof Plame Marg, Munirka, New Delhi-110067

M/s. Boston Scientific Corporation One Boston Scientific Place, Natick MA 01760-1537, USA having factory premises at M/s. Boston Scientific Corporation, Two Scimed Place Maple Grove, MN 55311-1566, USA

1. Apex Over-The-Wire PTCA Dilatation catheter

2. Maverick2 Monorail PTCA Dilatation Catheter

3. Express Vascular SD Premounted Stent System

4. Gateway PTA Balloon Catheter

31-857-MD/2010-DC MD-857 31-07-2014

167. M/s. Surgimed, D-22 Okhla Industrial Area, Phase-I, New Delhi-110020

M/s. Vascular Solutions Inc, 6464 Sycamore Court, Minneapolis, Minnesota 55369, USA

GuideLiner Catheter 31-202-MD/2006-DC (Re-reg. 2010) End 01

MD-202 14-09-2013


M/s. Zimmer Spine Inc, 5301 Riata Park Court, Building F, Austin, Tx 78727, USA

Sequoia Pedical e Screw System 31-864-MD/2010-DC MD-864 31-07-2014

169. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-

M/s. Acclarent Inc, 1525-B O’Brien Drive, Menlo Park, CA 94025

1. Relieva Solo Pro Sinus Balloon Catheter (with or without stylet)

2. Relieva Flex Sinus Guide

31-890-MD/2010-DC MD-890 31-07-2014

39

Bhiwandi Road, District-Thane, Bhiwandi

Catheter3. Relieva Vortex Sinus

Catheter4. Inspira Air Balloon

Dilation System170. M/s. Zimmer India

Private Limited, Plot No. B & B1, Vanijya Nikunj, 7th Floor, Enkay Tower, Udyog Vihar, Phase-V, Gurgaon-122016


NCB Polyaxial Locking Plate System

31-171-MD/2006-DC (Re-Reg. 2009) End 02

MD-171 31-07-2012

171. M/s. Teleflex Medical private Limited, Old No. 10, No. 19, 1st Floor, Ground Floor, Harrington Road, Chetpet, Chennai-600031

M/s. Teleflex Medical, IDA Business and technology Park, Athlone, Ireland having factory premises at M/s. Teleflex Medicals Sdn. Bhd. Lot no PT2577, Jalan Perusahaan 4, Kamunting Industrial Estate, 34600 Kamunting Perak, Malaysia Germany

Tracheal Tube (Teleflex ISIS Tracheal Tubes-Catalogue#112662)

31-851-MD/2010-DC MD-851 31-07-2014

172. M/s. Johnson & Johnson Limited, J-1, Shree Arihant Complex, Vill. Kalher, Thane-Bhiwandi Road, District-Thane, Bhiwandi

M/s. Mentor, 3041 Skyway Circle North, Irving, Texas 75038, USA having factory premises at M/s. Genzyme Biosurgery, 1125 Pleasant View, Terrace, Ridgefield, New Jersy 07657, USA

Prevelle Silk Dermal Filler 31-879-MD/2010-DC MD-879 31-07-2014

173. M/s. Mn Solutions, Shop No. 26-27, 2nd Floor, Prop. No. WZ-26, Nangli Jalib Village,

M/s. Arthrocare Corporation, 680 Vagueros Avenue, Sunnyvale, CA 94085,

1. Opus Anchor Sutures-Rotator Cuff Repairs

2. Opus Anchor Sutures for Labral Repair

31-774-MD/2010-DC MD-774 31-07-2014

40

Janak Puri, New Delhi-110058

USA having factory premises at M/s. Arthrocare Costa Rica 502, Global Parkway, Global Park, la Aurora Heredia, Costa Rica

174. M/s. B L Lifesciences Private Limited, a-245, Okhla Industrial Area, Phase-I, New Delhi-110020

M/s. Kinamed Incorporated, 820 Flynn Road, Camarillo, California 93012-8701, USA

NeuroPro the complete Neurosurgical Rigid Fixation System (Non-Sterile)

31-237-MD/2010-DC (Re-Reg. 2010)

MD-237 31-07-2014

41

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