Data / Medical devices / China / Winner Medical (Huanggang) Co., Ltd.
Winner Medical (Huanggang) Co., Ltd.: FDA-registered device maker in Huanggang Hubei, China, 1 510(k) clearance
Winner Medical (Huanggang) Co., Ltd. is registered with the FDA (registration 3007966889) in Huanggang Hubei, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 3, 1989. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007966889
- Address
- Winner Industrial Park, Te1,Chibi Road, Huanggang Hubei, China, 438000
- Owner or operator
- WINNER MEDICAL CO., LTD. (9012349)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- January 24, 2000
- Registered through
- 2026
- Brand names listed
- ADHESIVE TAPE AND BANDAGE, ALMORIS Alginate Wound Dressing, ATHLETIC TAPE, Absorbent towel, Activated Charcoal Super Absorbent Dressing, Ag Foam Dressing Adhesive, Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border, Ag Foam Dressing Non-adhesive and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Contract manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 3, 1989 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | Substantially Equivalent | Ashton Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Fiber, Medical, Absorbent
- All makers of Mask, Surgical
- All makers of Tape And Bandage, Adhesive
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dressing, Wound, Occlusive
Updated November 3, 1989. 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.