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.
Devices declared under this manufacturer
- KBA3D
- KHEIRON
Showing 12 of 488 declared devices.
Catalogue references include 24BT0050, 24PW95080, 24TS05991, 24TS65991, 25SC55003, 25SP55302.
European nomenclature codes declared: P09070302, L0999, S010401, L0922, L26, L031199.
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 |
Device-level evidence
| Devices with a numeric GTIN | 488 |
|---|---|
| Found in the U.S. device database | 443 |
| Share | 90.8 % |
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: United States only. S.M.A.I.O is registered in the United States but was not found in the Canadian register.