Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616433

FEI Number

3005076849

Entity Name

WINNER MEDICAL CO., LTD.

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

Winner Industrial Park, No. 660 Bulong Road, Longhua District, SHENZHEN Guangdong 518109, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

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

K023755

PMA Number

N/A

All Registered Proprietary Names

alcohol device disinfectant 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 Hearing Aid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2017-07-20
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-08-06
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2024-03-04
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2007-12-21

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
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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616433. Last updated year: 2026. Please use registration number 9616433 when referencing this establishment in official correspondence.