Sutures India Pvt. Ltd. has obtained U.S.F.D.A. approval to market the following medical devices in U.S. market.

1. ABSORBABLE SUTURES

Device Name : TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture
Requlation Name : Absorbable Poly (glycolide/L-lactide) Surgical Suture
Requlation Number : 21 CFR 878.4493
Requlatory Class : II
Product Code : GAM
510(k) number : K 041515
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2. NONABSORBABLE SUTURES

a. Device Name : TRULON Nonabsorbable Polyamide surgical Suture
Requlation Name : Nonabsorbable Polyamide Surgical Suture
Requlation Number : 21 CFR 878.5020
Requlatory Class : II
Product Code : GAR
510(k) number : K 041510
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b. Device Name : TRULENE Nonabsorbable Polypropylene Surgical Suture
Requlation Name : Nonabsorbable Polypropylene Surgical Suture
Requlation Number : 21 CFR 878.5010
Requlatory Class : II
Product Code : GAW
510(k) number : K 041511

c. Device Name : TRUBOND Nonabsorbable Poly ethylene terephthalate Surgical Suture
Requlation Name : Nonabsorbable Poly ethylene terephthalate Surgical Suture
Requlation Number : 21 CFR 878.5000
Requlatory Class : II
Product Code : GAT
510(k) number : K 041512

d. Device Name : TRUSILK Nonabsorbable Silk Surgical suture
Requlation Name : Natural nonabsorbable Silk Surgical Suture
Requlation Number : 21 CFR 878.5030
Requlatory Class : II
Product Code : GAP
510(k) number : K 041514

e. Device Name : TRULENE MESH TRULENE MESH Nonabsorbable Polypropylene Surgical Mesh
Requlation Name : SURGICAL MESH
Regulation Number : 21 CFR 878.3300
Regulatory Class : II
Product Code : FTL
510(k) Number : K 060018

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ISO 9001:2000

Class of devices : Surgical Sutures & Surgical Mesh
Certification : ISO 9001:2000
Certificate Number : 02977-2005-AQ-BOM-RvA

ISO 13485:2003

Class of devices : Surgical Sutures & Surgical Mesh
Certification: : ISO 13485 : 2003
Certificate Numbed:\satendermail\attach\iso-9001-new.jpgr : 2005-OSL-AQ-0353

Sutures India Pvt. Ltd. has obtained CE approval for the following products.

1. ABSORBABLE SUTURES

Device Name : Truglyde
Requlation Name : Absorbable Surgical Suture, U.S.P. (Synthetic )
Certificate Number: : 2002-OSL-MDD-0143
Requlatory Class : III

2. NONABSORBABLE SUTURES

Device Name : Trulene, Trusilk, Trulon and Trubond
Requlation Name : Nonabsorbable Surgical Sutures, U.S.P.
Certificate Number : 2002-OSL-MDD-0144
Requlatory Class : IIb

Sutures India Pvt. Ltd. has obtained WHO GMP approval for the following products

1. TRUGLYDE SUTURES

Device Name : TRUGLYDE Braided and Coated Polyglycolic Acid
Requlation Name : Absorbable surgical suture, U.S.P. (Synthetic)
Certificate Number : DCD/CR-394/Spl-cl/05-06

2. TRUGUT WITHOUT NEEDLE SUTURES

Device Name : TRUGUT Catgut Chromic Needled
Requlation Name : Absorbable surgical suture, U.S.P. (Catgut Chromic)
Certificate Number : DCD/CR-394/Spl-cl/05-06

3. TRUGUT CATGUT CHROMIC SUTURES WITH NEEDLE

Device Name : TRUGUT Catgut Chromic Needled
Requlation Name : Absorbable Surgical suture, U.S.P. (Catgut Chromic)
Certificate Number : DCD/CR-394/Spl-cl/05-06

4. TRUGUT PLAIN SUTURES

Device Name : TRUGUT Catgut Plain
Requlation Name : Absorbable surgical suture, U.S.P. (Catgut Plain)
Certificate Number : DCD/CR-394/Spl-cl/05-06

5. TRUBOND COATED POLYESTER SUTURES

Device Name : TRUBOND Coated Polyester
Requlation Name : Nonabsorbable Surgical suture, U.S.P.
Certificate Number : DCD/CR-394/Spl-cl/05-06

6. TRUSILK SUTURES

Device Name :TRUSILK Black Braided Silk
Requlation Name : Nonabsorbable Surgical suture, U.S.P.
Certificate Number : DCD/CR-394/Spl-cl/05-06

7. TRULON Monofilament Polyamide SUTURES

Device Name : TRULON Monofilament Polyamide Sutures
Requlation Name : Nonabsorbable Surgical suture, U.S.P.
Certificate Number : DCD/CR-394/ Spl-cl/5-06