Osatu Sociedad Cooperativa
ES-MF-000004710 · Spain · Ermua-Bizkaia
Osatu Sociedad Cooperativa is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 27 |
|---|---|
| Class IIb | 3 |
Most frequent device types declared: Reanibex 300 / Reanibex 500.
Among these devices, 30 are declared active, 29 with a measuring function.
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 | 30 |
| 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 |
|---|---|---|
1000291268 | supplemented | 2030-03-26 |
1000291267 | supplemented | 2030-03-26 |