oniris
FR-MF-000014182 · France · Rueil-Malmaison
oniris is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 24 |
|---|
Devices declared under this manufacturer
- ONIRIS
- ONIRIS PLUS
Showing 12 of 24 declared devices.
Catalogue references include ONIPLUSBEL, ONIPLUSES, ONIPLUSSPT2, ONIPRO2BEL, ONIPRO2ES, ONIPRO2HOL.
European nomenclature codes declared: Q03010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ONIRIS (FR) · FDA 3013548547 |
| Devices in EUDAMED | 24 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 24 |
|---|---|
| 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: United States only. oniris is registered in the United States but was not found in the Canadian register.