Borea
FR-MF-000015596 · France · Limoges
Borea is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 5 |
|---|
Most frequent device types declared: Cobra, Rayplicker Cobra.
Among these devices, 5 are declared reusable, 5 active.
Devices declared under this manufacturer
- Cobra
- DEXTA CHROMA
- Rayplicker Cobra
- Rayplicker Handy
- WE SHADE
Catalogue references include RP0001, RP0201, SF0216, SF0226, SF0246.
European nomenclature codes declared: Q0199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 5 |
|---|---|
| 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. Borea was not found in either the U.S. or the Canadian register.