Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031180770

FEI Number

3031180770

Entity Name

Winner Medical (Wuhan) Co., Ltd.

City/State/Country

Wuhan Hubei, CN

Establishment Address

No. 8th Wuyang Avenue North, Yangluo Economic Development Zone, Wuhan Hubei 430415, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

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

LARGE STERILE GAUZE PAD PC swabs without X-ray thread Conforming stretch gauze DRYNET Antimicrobial Gauze Sponge Dressing, Antimicrobial Super Sponge Dressing, Antimicrobial Non-Woven Sponge Dressing Sterilux AMD Sterile Bulky Antimicrobial Gauze Antimicrobial Super Sponge Dressing, 4.5''X4.1YDS-6P, EO Antimicrobial Super Sponge Dressing 32/12X5,6X6"-12P,2S,EO 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 Minor Procedure Drape with Adhesive Aperture Fenestrated drape Drape Absorbent drape JOBST Comprifore Sting Free Skin Barrier Wipe Skin barrier film spray Skin barrier film wand Suture Removal kit,Tracheostomy Care Kit,Laceration Trays,IV START KIT,SHAVE PREP KIT Dispossable Dressing Tray Antimicrobial non-woven sponge dressing (OTC) Antimicrobial gauze sponge dressing (OTC) Antimicrobial super sponge dressing (OTC)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2010-05-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-03-15
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
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-09-01
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2000-01-24
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2019-05-24
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-07-08
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2000-01-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-20

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
3008132238	Winner Medical (Jiayu) Co., Ltd.	Jiayu Hubei, CN
3030067857	WINNER MEDICAL CO., LTD.	SHENZHEN Guangdong, 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

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3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3043106338	SHENZHEN SPONGE NEW MATERIAL CO. LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031180770. Last updated year: 2026. Please use registration number 3031180770 when referencing this establishment in official correspondence.