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.
Devices declared under this manufacturer
- REANIBEX-300 AED CZECH
- REANIBEX-300 AED ENGLISH
- REANIBEX-300 AED ENGLISH + PUSHPAD OPTION
- REANIBEX-300 AED ITALIAN + GSM TRANSMISSION
- REANIBEX-300 AED ITALIAN + PUSHPAD OPTION
- REANIBEX-300 AED SERBIAN
- REANIBEX-300 AED SPANISH
- REANIBEX-300 AED SPANISH +IrDA sensor
- REANIBEX-500AL EMS+Sp+MP+BT+pP+ET+NI
- REANIBEX-500AL EMS+Sp+pP+ET
- REANIBEX-500ES_EMS+Sp+MP+pP+ET+NI
- REANIBEX-500IN EMS+GSM+pP
Showing 12 of 30 declared devices.
Catalogue references include DGA, DIA0959A0000001, DIA0991B0000001, DIA2348B0000002, DIA2348K0000001, DIA2350A0000002.
European nomenclature codes declared: Z1203020202,Z1203020401,Z1203020408,Z12030501,Z12030502,Z12050301,Z12050302, Z12030501, Z12030501,Z12030502, Z1203020202,Z1203020401,Z1203020408,Z12030501,Z12030502,Z12050301,Z12050302,Z12050803, Z12030501,Z12050803, Z12030501,Z12030503.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 30 |
| Country of registration | Spain |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 27 |
|---|---|
| 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. Osatu Sociedad Cooperativa was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1000291268 | supplemented | 2030-03-26 |
1000291267 | supplemented | 2030-03-26 |