Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008132238

FEI Number

3008132238

Entity Name

Winner Medical (Jiayu) Co., Ltd.

City/State/Country

Jiayu Hubei, CN

Establishment Address

No. 172, Fenghuang Avenue, Jiayu Hubei 437200, 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

Cotton Roll, Cotton Ball Extra Silver Gelling Fiber Dressing Sting Free Skin Barrier Wipe Skin barrier film spray Skin barrier film wand Antibacterial Gel Wound Dressing Super Absorbent Dressing Alginate Dressing Nonwoven Adhesive wound dressing (Strip) CMC Gelling Fiber Dressing Wound Dressing ALMORIS Alginate Wound Dressing Activated Charcoal Super Absorbent Dressing Silicone Super Absorbent Dressing transparent dressing Silicone Absorbent Soft Dressing with border HidraWear Superabsorbent Dressing Calcium Alginate Wound Dressing Hydrogel Wound Gel Tape remover pad Adhesive Romover Wipes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFN	Cotton, Roll	Dental	Class 1	872.6050	2002-05-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-20
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2019-05-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-20
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-08-06
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2019-02-18
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2020-06-10
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-09-30

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
3031238659	Winner Medical Co., Ltd., Shenzhen Branch	Shenzhen Guangdong, CN
9616433	WINNER MEDICAL CO., LTD.	SHENZHEN Guangdong, 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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3005621808	ANJI HONGDE MEDICAL PRODUCTS CO., LTD.	HUZHOU Zhejiang, CN
3016826509	TAIZHOU RICH MEDICAL PRODUCTS CO., LTD.	TAIZHOU Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008132238. Last updated year: 2026. Please use registration number 3008132238 when referencing this establishment in official correspondence.