Optima Medical Swiss AG
CH-MF-000041543 · Switzerland · Zug
Optima Medical Swiss AG is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 16 |
|---|---|
| Class IIb | 13 |
Most frequent device types declared: TD OM 06, TD OM 07, TD OM 05, TD OM 09, TD OM 02.
Among these devices, 17 are declared sterile.
Authorised representative in the Union: IT-AR-000028430.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 29 |
| Country of registration | Switzerland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
7086GB448260225 | supplemented | 2028-10-17 |