Biosensors Europe SA
CH-MF-000015764 · Switzerland · Morges
Biosensors Europe SA is registered in the European database on medical devices as a manufacturer, with 223 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 223 |
|---|
Most frequent device types declared: BFC1-2224, BFR1-2718, BFR1-2728, BFR1-3014, BMX6-2209.
Among these devices, 223 are declared sterile, 166 implantable.
Authorised representative in the Union: NVT GmbH.
Devices declared under this manufacturer
- BioMatrix Alpha Drug Eluting Coronary Stent System
Showing 12 of 223 declared devices.
Catalogue references include BFC1-2224, BFR1-2728, BMX6-2224, BMX6-2714, BMX6-3533, NCB-22512.
European nomenclature codes declared: P070402010302, P070402010301, C010401020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 223 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 223 |
|---|---|
| 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. Biosensors Europe SA was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
TD745.151 | issued | 2031-03-12 |
745.151 | issued | 2031-03-12 |