FDA device listing
andorate,ENDO0209AUS,ENDO0209US,ENDO044FUS,ENDO044US
FDA device listing 1064611471 · GA Health Company Limited
Key facts
| Proprietary names | andorate,ENDO0209AUS,ENDO0209US,ENDO044FUS,ENDO044US |
|---|---|
| Owner/operator | GA Health Company Limited |
| Owner/operator number | 10061258 |
| Product codes | MNK |
| Device names | MNK - Endoscopic Bite Block |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | GA HEALTH COMPANY LIMITED |
| Establishment registrations | 3014749926 |
| FEI numbers | 3014749926 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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