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Bc-1
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 77735155Model BC-1-BONE-W-HEADBAND/GR7024Ref 77735337Model BC-1-BONE-W-HEADBAND/SET/GR7024
Identity
- Trade Name
- BC-1 EUDAMEDFDA UDI
- Generic Name
- Auditory cranial bone vibrator FDA UDI
- Device Name
- BC-1 EUDAMEDAudiometric receiver with headband FDA UDI
- Model / Reference
- BC-1-BONE-W-HEADBAND/GR7024 EUDAMEDFDA UDI77735155 EUDAMEDBC-1-BONE-W-HEADBAND/SET/GR7024 EUDAMED77735337 EUDAMED
- Description
- Audiometric receiver with headband FDA UDI
Identifiers
- Catalog Number
- 77735155 FDA UDI
- Primary DI / UDI-DI
- 09120041051661 EUDAMEDFDA UDI09120041059926 EUDAMED
- Basic UDI-DI
- B-09120041051661 EUDAMEDB-09120041059926 EUDAMED
- 510(k) Number
- K102199 FDA UDI
- FDA Product Code
- LXB FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Auditory cranial bone vibrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bc-1 by BHM-Tech Produktionsgesellschaft m.b.H. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-09120041051661 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BHM-Tech Produktionsgesellschaft m.b.H.
- EUDAMED SRN
- AT-MF-000020414
Sources (3)
- EUDAMED 39e32328-8676-4611-9fed-f04df5c0dba3 61 fields · synced Jul 29, 2026
- EUDAMED 8b2bf693-4b5e-4f85-bdd1-4adf8fbcc46a 61 fields · synced May 17, 2026
- FDA UDI 53e7c8ea-38a0-4da9-81d5-d26748fa33aa 37 fields · synced May 29, 2026