OTOFARMA SPA
IT-MF-000035472 · Italy · NAPOLI
OTOFARMA SPA is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 15 |
|---|---|
| Class I | 1 |
Most frequent device types declared: CIC ATOM, CIC SATURN, CIC SILVER PLUS PLUS, CIC VENUS STANDARD, Endo ATOM.
Among these devices, 16 are declared active.
Catalogue references include CIC ATOM, CIC SATURN, CIC VENUS STANDARD, Endo ATOM, Endo IRON, Retro Micro IRON.
European nomenclature codes declared: Y2145060202, Y2145060101, Y2145060203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| 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 | 16 |
|---|---|
| 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. OTOFARMA SPA was not found in either the U.S. or the Canadian register.