FDA device listing
Barrier Covers,Barrier Film
FDA device listing 1673971239 · HENAN BAISTRA MEDICAL DEVICES LIMITED
Key facts
| Proprietary names | Barrier Covers,Barrier Film |
|---|---|
| Owner/operator | HENAN BAISTRA MEDICAL DEVICES LIMITED |
| Owner/operator number | 10085746 |
| Product codes | FRK |
| Device names | FRK - Chair, Examination And Treatment |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6140 |
| Review panels | General Hospital |
| Registered establishments | HENAN BAISTRA MEDICAL DEVICES LIMITED |
| Establishment registrations | 3023443842 |
| FEI numbers | 3023443842 |
| Establishment operations | Foreign Exporter, 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