FDA device listing
LUOFUCON Foam Dressing,LUOFUCON Silicone Film Dressing,LUOFUCON Silicone Foam Dressing,Silicone Wound Contact Dressing
FDA device listing 1118712561 · HUIZHOU FORYOU MEDICAL DEVICES CO LTD
Key facts
| Proprietary names | LUOFUCON Foam Dressing,LUOFUCON Silicone Film Dressing,LUOFUCON Silicone Foam Dressing,Silicone Wound Contact Dressing |
|---|---|
| Owner/operator | HUIZHOU FORYOU MEDICAL DEVICES CO LTD |
| Owner/operator number | 10029091 |
| 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 | HUIZHOU FORYOU MEDICAL DEVICES CO.,LTD. |
| Establishment registrations | 3007735241 |
| FEI numbers | 3007735241 |
| 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