Data / Medical devices / China / Winner Medical Co., Ltd.
Winner Medical Co., Ltd.: FDA-registered device maker in SHENZHEN Guangdong, China, 1 510(k) clearance
Winner Medical Co., Ltd. is registered with the FDA (registration 9616433) in SHENZHEN Guangdong, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 10, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616433
- FEI number
- 3005076849
- Address
- Winner Industrial Park, No. 660 Bulong Road Longhua District, SHENZHEN Guangdong, China, 518109
- Owner or operator
- WINNER MEDICAL CO., LTD. (9012349)
- Roles
- Exporter to the US
- First device listed
- December 21, 2007
- Registered through
- 2026
- Brand names listed
- ALMORIS Alginate Wound Dressing, Activated Charcoal Super Absorbent Dressing, Alginate Dressing, CMC Gelling Fiber Dressing, Calcium Alginate Wound Dressing, Dimora HEEL FOAM DRESSING Without Borde, Foam Dressing, Foam dressing without border and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 10, 2003 | K023755 | WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD | FXX | Substantially Equivalent | Winner Industries (Shenzhen) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Hearing Aid, Air-Conduction, Over The Counter
- All makers of Mask, Surgical
- All makers of Pad, Alcohol, Device Disinfectant
- All makers of Dressing, Wound, Occlusive
Updated June 10, 2003. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.