Ceram Optec SIA
LV-MF-000021846 · Latvia · Riga
Ceram Optec SIA is registered in the European database on medical devices as a manufacturer, with 185 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 179 |
|---|---|
| Class IIb | 6 |
Among these devices, 179 are declared sterile, 6 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 | Registered with FDA |
|---|---|
| Matched entry | CERAMOPTEC GMBH (DE) · FDA 3003340844 |
| Devices in EUDAMED | 185 |
| Country of registration | Latvia |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1487000011 | supplemented | 2028-05-24 |