O.M.S. S.P.A. OFFICINE MECCANICHE SPECIALIZZATE
IT-MF-000010171 · Italy · SELVAZZANO DENTRO
O.M.S. S.P.A. OFFICINE MECCANICHE SPECIALIZZATE is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Among these devices, 7 are declared active.
Devices declared under this manufacturer
- ARCADIA EXT
- ARCADIA P
- CARVING 2025
- DB6
- DB7
- MOON
- SWAN
Catalogue references include ARCADIA EXT, ARCADIA P, CARVING 2025, DB6, DB7, MOON.
European nomenclature codes declared: Z12011201, Z12110101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| 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. O.M.S. S.P.A. OFFICINE MECCANICHE SPECIALIZZATE was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT350642 | issued | 2030-03-04 |
281/MDR | issued | 2031-06-25 |