FDA device listing
Adult Biteguard,Clip-On Biteguard,Gastroguard,Pediatric Biteguard,Scanhead protection cover,Soft Adult…
FDA device listing 1866925788 · Inoris Medical Sp. z o.o.
Key facts
| Proprietary names | Adult Biteguard,Clip-On Biteguard,Gastroguard,Pediatric Biteguard,Scanhead protection cover,Soft Adult Biteguard,Tubeguard |
|---|---|
| Owner/operator | Inoris Medical Sp. z o.o. |
| Owner/operator number | 10046303 |
| 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 | INORIS MEDICAL SP. Z O.O. |
| Establishment registrations | 3010806663 |
| FEI numbers | 3010806663 |
| Establishment operations | 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