Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030067857

FEI Number

3030067857

Entity Name

WINNER MEDICAL CO., LTD.

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

42F, Building No.2, HBC Huilong Business Center, North Station Community, Minzhi Street, Longhua District, SHENZHEN Guangdong 518131, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,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

K221720

PMA Number

N/A

All Registered Proprietary Names

Hydrogel Wound Gel Surgical tape, Cohesive bandage, Elastic adhesive bandage Soft Silicone Tape,Silicone Band Aid ATHLETIC TAPE Medical Silicone Tape Silicone Adhesive Tape ADHESIVE TAPE AND BANDAGE Silicone tape non-surgical isolation gown Surgeon Gown 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 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 Sting Free Skin Barrier Wipe Skin barrier film spray Skin barrier film wand Skin and Wound Cleanser Silicone Ag Foam Dressing Ag Foam Dressing Adhesive Silicone Ag Foam Dressing with Border Ag Foam Dressing Non-adhesive PHMB Foam Dressing PHMB non-adhesive foam dressing PHMB sacral bordered silicone foam dressing with SAF PHMB bordered foam dressing PHMB bordered silicone foam dressing with SAF Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border Suture Removal kit,Tracheostomy Care Kit,Laceration Trays,IV START KIT,SHAVE PREP KIT Dispossable Dressing Tray SURGICALCAPS alcohol device disinfectant Cotton Roll, Cotton Ball Minor Procedure Drape with Adhesive Aperture Fenestrated drape Drape Absorbent drape X-RAY DETECTABLE GAUZE SPONGES LARGE STERILE GAUZE PAD PC swabs without X-ray thread Conforming stretch gauze DRYNET 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 Extra Silver Gelling Fiber Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2000-01-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2022-09-30
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2019-02-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2000-01-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2008-05-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-12-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-03-15
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2013-01-26
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-12-14
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
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-04-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-12-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-07-08
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2000-01-24
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2017-07-20
EFN	Cotton, Roll	Dental	Class 1	872.6050	2002-05-07
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-09-01
POR	Parenteral Administration Kit	General Hospital	Class 2	880.5440	2025-09-09
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2002-05-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2010-05-07
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2003-12-30
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-01-13
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-08-06
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
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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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.

Similar Registrations

Registration Number	Establishment Name	Location
3045061271	YANGZHOU HUANRUI MEDICAL TECHNOLOGY CO., LTD	Baoying County Jiangsu, CN
1932902	CERTIFIED SAFETY MFG., INC.	KANSAS CITY, MO, US
3014819517	WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD.	Suzhou Jiangsu, CN
1422634	MEDLINE INDUSTRIES, LP (Northpoint Services)	Waukegan, IL, US
3012865799	NEOMED CO., LTD.	Saha-gu Busan, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030067857. Last updated year: 2026. Please use registration number 3030067857 when referencing this establishment in official correspondence.