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: Aplikátory BIOMAG®, BIOMAG® Lumina 3D-e s aplikátory, A13P, A1P, A7S.
Among these devices, 34 are declared 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 | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 34 |
| Country of registration | Czechia |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2024-MDR/QS-001/A | supplemented | 2029-01-31 |