Certificados

SUTURES INDIA'S PRODUCTS WITH U.S.F.D.A. APPROVAL.

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

Sutures India Pvt Ltd.

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 1

Sutures India Pvt Ltd.

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

Sutures India Pvt Ltd.

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

Sutures India Pvt Ltd.

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

Sutures India Pvt Ltd.

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

Sutures India Pvt Ltd.
SUTURES INDIA'S ISO APPROVAL.

ISO 9001:2000

Class of devices : Surgical Sutures & Surgical Mesh
Certification : ISO 9001:2000
Certificate Number : 02977-2005-AQ-BOM-RvA8

Sutures India Pvt Ltd.

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.
SUTURES INDIA'S PRODUCTS WITH CE APPROVAL.

ABSORBABLE SUTURES

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

Sutures India Pvt Ltd.

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.