Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031238659

FEI Number

3031238659

Entity Name

Winner Medical Co., Ltd., Shenzhen Branch

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Winner Medical Industry Building, No. 66, Liguang Industrial Road, Guanlan Sub-district,, Longhua District, 518110, Shenzhen , China, Shenzhen Guangdong 518110, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WINNER MEDICAL CO., LTD. (Owner Number: 9012349)

Owner / Operator Contact Address

42nd Floor, Building No.2, Huilong Business Center, Longhua District, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Minor Procedure Drape with Adhesive Aperture Fenestrated drape Drape Absorbent drape Collagen Wound Dressing Wound Dressing With Animal-Derived Material(S)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-09-01
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2023-12-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-01-13

Official Correspondent

Xiaomeng Yang

US Agent Details

DAVID LENNARZ Business: REGISTRAR CORP Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

WINNER MEDICAL CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3035744034	NATURE HEALTH DEVELOPMENT(HONG KONG)CO.,LIMITED	Hong Kong, CN
9616433	WINNER MEDICAL CO., LTD.	SHENZHEN Guangdong, CN
3008132238	Winner Medical (Jiayu) Co., Ltd.	Jiayu Hubei, CN
3030067857	WINNER MEDICAL CO., LTD.	SHENZHEN Guangdong, CN
3036978602	Winner Medical (Jiayu) Co., Ltd.	Jiayu Hubei, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031238659. Last updated year: 2026. Please use registration number 3031238659 when referencing this establishment in official correspondence.