FDA device listing
Non-surgical gown
FDA device listing 1209548250 · ANJI HUIFENG SURGICAL DRESSINGS CO., LTD.
Key facts
| Proprietary names | Non-surgical gown |
|---|---|
| Owner/operator | ANJI HUIFENG SURGICAL DRESSINGS CO., LTD. |
| Owner/operator number | 9055309 |
| 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 | ANJI HUIFENG SURGICAL DRESSINGS CO., LTD. |
| Establishment registrations | 3003967959 |
| FEI numbers | 3003967959 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Foreign Private Label Distributor, Manufacturer, Remanufacturer, Repackager/Relabeler, Reprocessor of Single Use Devices, 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