BIOSYSTEMS S.A.
ES-MF-000000231 · Spain · BARCELONA
BIOSYSTEMS S.A. is registered in the European database on medical devices as a manufacturer, with 372 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| other | 372 |
|---|
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 372 |
| Country of registration | Spain |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HX 1695779-1 | supplemented | 2030-02-24 |