CeramOptec GmbH
DE-MF-000005607 · Germany · Bonn
CeramOptec GmbH is registered in the European database on medical devices as a manufacturer, with 216 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 195 |
|---|---|
| Class IIb | 21 |
Most frequent device types declared: Vaginal Handpiece, Coupling Fiber, ELVeS® smart.
Among these devices, 187 are declared sterile, 23 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 | 216 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1486900015 | supplemented | 2028-05-16 |