Optima Sanità S.r.l.
IT-MF-000028431 · Italy · Bolzano (BZ)
Optima Sanità S.r.l. 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 |
|---|
Most frequent device types declared: TD OS 01, TD OS 04.
Among these devices, 4 are declared sterile.
Devices declared under this manufacturer
- Lento Nit K
- Lipo Nit
- OtoCura
- Waxonova
Catalogue references include 260010, 260030, 300040, 300041, 310045, 310046.
European nomenclature codes declared: Q02030206, V9099.
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.
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. Optima Sanità S.r.l. was not found in either the U.S. or the Canadian register.