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Bone Conductor (BC-2)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 041545Model Bone Conductor
Identity
- Trade Name
- Bone Conductor (BC-2) FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Bone Conductor (BC-2) EUDAMEDBC-2 Bone Conductor With Headband FDA UDI
- Model / Reference
- Bone Conductor EUDAMED041545 EUDAMEDFDA UDI
- Description
- BC-2 Bone Conductor With Headband FDA UDI
Identifiers
- Catalog Number
- 041545 FDA UDI
- Primary DI / UDI-DI
- 05713315009969 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA001445H EUDAMED
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Tone audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 FDA UDI
- Market of Registration
- Denmark 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bone Conductor (BC-2) by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5713315NA001445H | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED bc79ebc7-6381-45e2-8e57-85b8a19202f7 61 fields · synced Jul 20, 2026
- FDA UDI 88b1e59f-388e-48af-87da-0e704e855b0c 34 fields · synced May 30, 2026