FDA device listing
Non-Surgical Gown
FDA device listing 1178115076 · SHANGHAI HUA EN INDUSTRIAL CO LTD
Key facts
| Owner/operator | SHANGHAI HUA EN INDUSTRIAL CO LTD |
|---|---|
| Owner/operator number | 10043241 |
| Product codes | OEA |
| Device names | OEA - Non-Surgical Gown |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4040 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Shanghai Hua En Industrial Co Ltd |
| Establishment registrations | 3010147274 |
| FEI numbers | 3010147274 |
| Establishment operations | Foreign Exporter |
| 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