Winner Medical Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 25 device types, 8 products catalogued, 18 clearances.
Winner Medical Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Pad, Eye, Cotton, Roll and 23 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2000.
25device types registered with the FDA
8products catalogued under its own name
18510(k) clearances
Registration
| Registered name | WINNER MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3030067857 |
| FEI number | 3030067857 |
| DUNS | 530629351 |
| Establishment type | Specification developer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 稳健医疗用品股份有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 42F, Building No.2, HBC Huilong Business Center, North Station Community, Minzhi Street, Longhua District |
| Postal code | 518131 |
| Country | China |
Group
Winner Medical Co., Ltd. is one of 8 plants registered under WINNER MEDICAL CO., LTD..
| Plant | City | Device types |
|---|---|---|
| Winner Medical (Chongyang) Co., Ltd. | Chongyang | 13 |
| Winner Medical (Wuhan) Co., Ltd. | Wuhan | 9 |
| Nature Health Development(Hong Kong)Co., Limited | Hong Kong | 2 |
| Winner Medical (Jiayu) Co., Ltd. | Jiayu | 7 |
| Winner Medical (Huanggang) Co., Ltd. | Huanggang | 9 |
| Winner Medical Co., Ltd., Shenzhen Branch | Shenzhen | 2 |
| Nature Health Trading (Hong Kong) Co., Limited | Hongkong | 1 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Elastic | Class 1 | JOBST Comprifore | 2000 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | Sting Free Skin Barrier Wipe, Skin barrier film wand, Skin barrier film spray | 2019 | 41 |
| Cap, Surgical | Class 1 | Surgicalcaps | 2000 | 178 |
| Cotton, Roll | Class 1 | Cotton Roll, Cotton Ball | 2002 | 107 |
| Drape, Surgical, Exempt | Class 2 | Minor Procedure Drape with Adhesive Aperture, Drape, Absorbent drape, Fenestrated drape | 2019 | 107 |
| Dressing, Wound, Drug | Class U | Cellasorb Ag+ Gelling Fiber Dressing with Antibacterial Silver, Antimicrobial gauze sponge dressing (OTC), Antimicrobial super sponge dressing (OTC), Antimicrobial non-woven sponge dressing (OTC), Antibacterial Gel Wound Dressing, Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border and 15 more | 2019 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | 2019 | 118 | |
| Dressing, Wound, Hydrophilic | Class 1 | Super Absorbent Dressing, Alginate Dressing, Nonwoven Adhesive wound dressing (Strip), Activated Charcoal Super Absorbent Dressing, Silicone Absorbent Soft Dressing with border, HidraWear Superabsorbent Dressing and 6 more | 2013 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Transparent Dressing, Silicone Contact Layer, Transparent Film Dressing, Foam Dressing, Hydrocolloid Dressing, Hydrocolloid (Sterile Wound Dressing with Border) and 9 more | 2013 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Silicone Scar Repair Sheet, Silicone Scar Gel, Silicone Scar Gel Ultra | 2020 | 85 |
| Fiber, Medical, Absorbent | Class 1 | PC Towel, Incontinence Underpads, Absorbent towel | 2002 | 172 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | PC swabs without X-ray thread, Conforming stretch gauze, Large Sterile Gauze PAD, Drynet | 2010 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | X-RAY Detectable Gauze Sponges | 2002 | 67 |
| Gown, Surgical | Class 2 | Surgeon Gown | 2023 | 68 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | Hearing Aid | 2024 | 57 |
| Kit, Surgical Instrument, Disposable | Class 1 | Suture Removal kit,Tracheostomy Care Kit,Laceration Trays,IV START KIT,SHAVE PREP KIT, Dispossable Dressing Tray | 2015 | 67 |
| Mask, Surgical | Class 2 | Surgical Face Mask, Medical Mask, Earloops Face Mask, Face Mask, Procedure Mask, Medical Face Mask and 3 more | 2007 | 125 |
| Non-Surgical Gown | Class 1 | non-surgical isolation gown | 2008 | 318 |
| Pad, Alcohol, Device Disinfectant | Class U | device disinfectant, alcohol | 2017 | 49 |
| Pad, Eye | Class 1 | 2000 | 100 | |
| Parenteral Administration Kit | Class 2 | 2025 | 5 | |
| Solvent, Adhesive Tape | Class 1 | Tape remover pad, Adhesive Romover Wipes | 2020 | 20 |
| Tape And Bandage, Adhesive | Class 1 | Surgical tape, Cohesive bandage, Elastic adhesive bandage, Soft Silicone Tape,Silicone Band Aid, Athletic Tape, Adhesive Tape AND Bandage, Medical Silicone Tape, Silicone tape and 1 more | 2000 | 353 |
| Tourniquet, Nonpneumatic | Class 1 | 2003 | 124 | |
| Wound Dressing With Animal-Derived Material(S) | Class U | Collagen Wound Dressing, Wound Dressing With Animal-Derived Material(S) | 2023 | 12 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| winner medical | FXX | 7 |
| Smith & Nephew | NAD | 7 |
| Hartmann | NAD | 5 |
| Winner | FXX | 4 |
Clearances
18 clearances name Winner Medical Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252001 | 2025-10-10 | KGN | Traditional | This company |
| K250082 | 2025-06-18 | FXX | Traditional | This company |
| K231057 | 2023-12-01 | FRO | Traditional | This company |
| K231564 | 2023-11-10 | FRO | Traditional | This company |
| K231152 | 2023-10-12 | KGN | Traditional | This company |
| K221311 | 2023-06-21 | FRO | Traditional | This company |
| K223232 | 2023-03-06 | FXX | Traditional | This company |
| K221532 | 2023-01-30 | FRO | Traditional | This company |
| K221754 | 2023-01-17 | FRO | Special | This company |
| K221755 | 2023-01-13 | FRO | Special | This company |
| K221720 | 2022-12-21 | FRO | Traditional | This company |
| K221819 | 2022-09-19 | FYA | Traditional | This company |
| K220194 | 2022-05-17 | FXX | Traditional | This company |
| K210466 | 2022-01-14 | FRO | Traditional | This company |
| K202982 | 2021-10-19 | FRO | Traditional | This company |
| K192463 | 2020-05-14 | FRO | Traditional | This company |
| K191819 | 2020-05-14 | FRO | Traditional | This company |
| K181315 | 2019-02-14 | FRO | Traditional | This company |
| K023755 | 2003-06-10 | FXX | Traditional | Winner Industries (Shenzhen) Co., Ltd. |
| K895077 | 1989-11-03 | FXX | Traditional | Ashton Medical Products, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1991 |
|---|---|
| Main products | infection control products, advanced wound dressings, traditional dressings, respiratory protection masks, personal care products |
| Certifications | Internet Pharmaceutical Information Service License |
| Export markets | 110+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.