FDA device listing
Absorbent pad,Chest Seal,Foam Dressing,Honey Gauze Dressing, Honey Calcium Alginate Dressing, Honey Gel,Oil Emulsion…
FDA device listing 1249542038 · Roosin Medical Co., Ltd.
Key facts
| Proprietary names | Absorbent pad,Chest Seal,Foam Dressing,Honey Gauze Dressing, Honey Calcium Alginate Dressing, Honey Gel,Oil Emulsion dressing,Paraffin gauze dressing,Petrolatum dressing,Silicone Foam Dressing,Super absorbent pad,Transparent dressing |
|---|---|
| Owner/operator | Roosin Medical Co., Ltd. |
| Owner/operator number | 10026552 |
| Product codes | NAD |
| Device names | NAD - Dressing, Wound, Occlusive |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4020 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Roosin Medical Co., Ltd. |
| Establishment registrations | 3007124979 |
| FEI numbers | 3007124979 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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