Identity
- Trade Name
- Bernafon EUDAMEDFDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- BERNAFON ENTRA B 10 IIC FDA UDI
- Model / Reference
- HI (ITE) EUDAMED276897 EUDAMEDFDA UDI
- Description
- BERNAFON ENTRA B 10 IIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464159031 EUDAMEDFDA UDI
- Basic UDI-DI
- 57144640-HI-00077-RZ EUDAMED
- FDA Product Code
- LRB FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060204 HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC) EUDAMED
- GMDN Term
- Air-conduction hearing aid, canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI874.3400 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Bernafon by Sbo Hearing A/S — 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 | 57144640-HI-00077-RZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (2)
- EUDAMED 03578098-07a3-49f9-9ba9-451995b180cb 61 fields · synced Jun 3, 2026
- FDA UDI 4c0443cd-6bb7-4060-b85e-9e445f1cfbdc 34 fields · synced May 30, 2026