Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007841320

FEI Number

3007841320

Entity Name

SMITH & NEPHEW (SUZHOU) LIMITED

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 12 Wuxiang Road, West Zone, Suzhou Industrial Park,, Suzhou Jiangsu 215021, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Smith & Nephew (Suzhou) Limited (Owner Number: 10034781)

Owner / Operator Contact Address

No. 12 Wuxiang Road, West Zone, Suzhou Industrial Park,, Suzhou, CN-JS 215021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OPSITE Flexigrid OPSITE POST Op OPSITE Flexifix OPSITE IV3000 Frame Delivery IV3000 IV3000 1-Hand IV3000 1-Hand Ported IV3000 Ported IV3000 standard OPSITE POST OP VISIBLE OPSITE VISIBLE DRAIN DRESSING INTRASITE Gel INTRASITE Gel Conformable CICA-CARE ALLEVYN Non Adhesive ALLEVYN Gentle Border Multisite ALLEVYN Gentle Border Sacrum ALLEVYN Gentle Border Lite ALLEVYN Gentle Border Heel ALLEVYN Life ALLEVYN Tracheostomy ALLEVYN Adhesive ALLEVYN Gentle ALLEVYN Gentle Border ALLEVYN Complete Care ALLEVYN LIFE ALLEVYN Gentle Border ALLEVYN Gentle Border Heel ALLEVYN Gentle Border Multisite ALLEVYN Gentle Border Sacrum ALLEVYN Gentle ALLEVYN Complete Care

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2010-12-31
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2013-11-29
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2013-11-29
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2010-12-31
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2016-03-18

Official Correspondent

Xianying Du

US Agent Details

Aarathi Arvind Business: Smith & Nephew, Inc. Email: aarathi.arvind@smith-nephew.com Phone: (978) 4746309

Related Public Records

Same Entity

Smith & Nephew (Suzhou) Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007841320. Last updated year: 2026. Please use registration number 3007841320 when referencing this establishment in official correspondence.