Karel Hrnčíř - BIOMAG
CZ-MF-000025009 · Czechia · Chomutice
Karel Hrnčíř - BIOMAG is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 34 |
|---|
Most frequent device types declared: A11P, A13P, A1P, A2P, A3P.
Among these devices, 34 are declared active.
Devices declared under this manufacturer
- Lumina 3D-e
- Lumio 3D-e
Showing 12 of 34 declared devices.
Catalogue references include A13P, A14P, A1P, A7S, LUMINA 3D-e CB, LUMINA 3D-e EB.
European nomenclature codes declared: Z120606.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 34 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 34 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Karel Hrnčíř - BIOMAG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2024-MDR/QS-001/A | supplemented | 2029-01-31 |