S.M.A.I.O
FR-MF-000002399 · France · SAINT-PRIEST
S.M.A.I.O is registered in the European database on medical devices as a manufacturer, with 488 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 328 |
|---|---|
| Class IIa | 160 |
Among these devices, 328 are declared implantable, 159 reusable, 1 active, 2 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 | Registered with FDA |
|---|---|
| Matched entry | S.M.A.I.O (FR) · FDA 3015383864 |
| Devices in EUDAMED | 488 |
| Country of registration | France |