FDA device listing
Collagen Wound Dressing
FDA device listing 1045103022 · Guangzhou Huada Biotechnology Co., Ltd.
Key facts
| Proprietary names | Collagen Wound Dressing |
|---|---|
| Owner/operator | Guangzhou Huada Biotechnology Co., Ltd. |
| Owner/operator number | 10043265 |
| Product codes | KGN |
| Device names | KGN - Wound Dressing With Animal-Derived Material(S) |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.KGN |
| Review panels | General & Plastic Surgery |
| Registered establishments | GUANGZHOU HUADA BIOTECHNOLOGY CO., LTD. |
| Establishment registrations | 3010187826 |
| FEI numbers | 3010187826 |
| Establishment operations | Contract Sterilizer |
| 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