Optikon 2000 S.p.A.
IT-MF-000017618 · Italy · Roma
Optikon 2000 S.p.A. is registered in the European database on medical devices as a manufacturer, with 182 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 114 |
|---|---|
| Class IIb | 68 |
Most frequent device types declared: Phaco Tips Wrench, 116001, 181007.
Among these devices, 140 are declared sterile, 75 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 182 |
| Country of registration | Italy |
⚠️ 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.