FDA device listing
Activated Charcoal Super Absorbent Dressing,Alginate Dressing,ALMORIS Alginate Wound Dressing,Calcium Alginate Wound…
FDA device listing 1183942208 · WINNER MEDICAL CO., LTD.
Key facts
| Proprietary names | Activated Charcoal Super Absorbent Dressing,Alginate Dressing,ALMORIS Alginate Wound Dressing,Calcium Alginate Wound Dressing,CMC Gelling Fiber Dressing,HidraWear Superabsorbent Dressing,Nonwoven Adhesive wound dressing (Strip),Silicone Absorbent Soft Dressing with border,Silicone Super Absorbent Dressing,Super Absorbent Dressing,transparent dressing,Wound Dressing |
|---|---|
| Owner/operator | WINNER MEDICAL CO., LTD. |
| Owner/operator number | 9012349 |
| Product codes | NAC |
| Device names | NAC - Dressing, Wound, Hydrophilic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4018 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Winner Medical (Chongyang) Co., Ltd., WINNER MEDICAL CO., LTD., Winner Medical (Huanggang) Co., Ltd., Winner Medical (Jiayu) Co., Ltd., Winner Medical (Wuhan) Co., Ltd. |
| Establishment registrations | 9616433, 3007966889, 3008132238, 3010610950, 3030067857, 3031180770, 3036978602 |
| FEI numbers | 3005076849, 3007966889, 3008132238, 3010610950, 3030067857, 3031180770, 3036978602 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database