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: Coupling Fiber, ELVeS® smart, Vaginal Handpiece.
Among these devices, 187 are declared sterile, 23 active.
Catalogue references include 501300415, 501805400, 503100145, 503200755, 503200775, 503725440.
European nomenclature codes declared: Z12011085, Z12011099, Z12011016, U0899, C0501, Z12011080.
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 |
Device-level evidence
| Devices with a numeric GTIN | 216 |
|---|---|
| Found in the U.S. device database | 13 |
| Share | 6.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CERAMOPTEC GMBH |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 2025-09-16 |
Licence types: Device Family (5), Device Group Family (2).
Licensed under: ELVES RADIAL FIBERS, ELVES RADIAL KIT, BARE FIBER, ORTHOPEDIC FIBERS, ENDOSCOPIC NEUROTOMY PROBES, BARE FIBER REUSABLE.
North American profile: Both markets. CeramOptec GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1486900015 | supplemented | 2028-05-16 |