Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010610950

FEI Number

3010610950

Entity Name

Winner Medical (Chongyang) Co., Ltd.

City/State/Country

Chongyang Hubei, CN

Establishment Address

No. 9A, Jincheng Avenue, Zhongjin Village, Tiancheng Town, Chongyang Hubei 437500, 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

X-RAY DETECTABLE GAUZE SPONGES 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 JOBST Comprifore 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 Suture Removal kit,Tracheostomy Care Kit,Laceration Trays,IV START KIT,SHAVE PREP KIT Dispossable Dressing Tray LARGE STERILE GAUZE PAD PC swabs without X-ray thread Conforming stretch gauze DRYNET Surgeon Gown Minor Procedure Drape with Adhesive Aperture Fenestrated drape Drape Absorbent drape Antimicrobial non-woven sponge dressing (OTC) Antimicrobial gauze sponge dressing (OTC) Antimicrobial super sponge dressing (OTC) Transparent Dressing Sacrum Silicone Foam Dressing with Border Silicone Contact Layer Transparent Film Dressing Foam Dressing Silicone Foam Dressing Hydrocolloid Dressing Silicone Foam Dressing with Border ALMORIS Silicone Foam Dressing Foam dressing without border Silicone Foam Dressing without Border Dimora HEEL FOAM DRESSING Without Borde HidraWear Foam Dressing Hydrocolloid (Sterile Wound Dressing with Border) Waterproof Foam Dressing Hydrocolloid Roll

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2002-05-07
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-08-06
POR	Parenteral Administration Kit	General Hospital	Class 2	880.5440	2025-09-09
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2000-01-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-03-15
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-07-08
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2010-05-07
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-12-20
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-09-01
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-20
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2000-01-24
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2013-01-26

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
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

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
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010610950. Last updated year: 2026. Please use registration number 3010610950 when referencing this establishment in official correspondence.