Identity
- Trade Name
- BC-1 EUDAMED
- Device Name
- BC-1 EUDAMED
- Model / Reference
- BC-1/GR7024 EUDAMED77735150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120041052378 EUDAMED
- Basic UDI-DI
- B-09120041052378 EUDAMED
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bc-1 by BHM-Tech Produktionsgesellschaft m.b.H. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09120041052378 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BHM-Tech Produktionsgesellschaft m.b.H.
- EUDAMED SRN
- AT-MF-000020414
Sources (1)
- EUDAMED 569ee398-b297-4ca6-91a1-b4e1407d7d16 61 fields · synced May 22, 2026