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.
Catalogue references include 501200775, 501200820, 501300366, 501300450, 503100410, 503200329.
European nomenclature codes declared: Z12011085, Z12011099, Z12011016, C0501, Z12011006.
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 |
Device-level evidence
| Devices with a numeric GTIN | 185 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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. Ceram Optec SIA is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
D1487000011 | supplemented | 2028-05-24 |