BiOSENCY
FR-MF-000007771 · France · Cesson Sévigné
BiOSENCY is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 9 |
|---|
Most frequent device types declared: BC4H-EXA-IC, Bora Band, NGDF.
Among these devices, 9 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- Bora Band
- Bora Connect
- Network Gateway device Firmware
Catalogue references include BB-100_A00, BP-100_AA0, BX-100_AAA, BX-100_AAB, BX-100_AAC, BX-100_AAE.
European nomenclature codes declared: V92, V0399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| 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 | 9 |
|---|---|
| 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. BiOSENCY was not found in either the U.S. or the Canadian register.