innOralis
FR-MF-000010971 · France · Belfort
innOralis is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 22 |
|---|---|
| Class IIb | 4 |
Most frequent device types declared: Wire CT8-1 Left, Wire CT8-1 Right, Wire CTO.
Among these devices, 4 are declared implantable, 2 reusable.
Devices declared under this manufacturer
- CT8 Micro-screw
- Chronomask Light
- Instrument à Baïonnette CT8
- Réglette de mesures intrabuccale
- Tournevis CT8
- Wire CT8-1 Left
- Wire CT8-1 Right
- Wire CTO
Showing 12 of 26 declared devices.
Catalogue references include 02_200, 02_400, 09_300, 09_300_40, 09_310, 14_100_1210.
European nomenclature codes declared: Q010499, L160201, Q010405, L150799, P09120601.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 26 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 26 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. innOralis was not found in either the U.S. or the Canadian register.