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Bernafon (Lisound)
EUDAMEDClass IIa (EU MDR)
Ref 222254Model HI (BTE)Ref 222252Ref 230629Ref 230631
Identity
- Trade Name
- Bernafon (Lisound) EUDAMED
- Model / Reference
- HI (BTE) EUDAMED222254 EUDAMED222252 EUDAMED230629 EUDAMED230631 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464010622 EUDAMED05714464010028 EUDAMED05714464031269 EUDAMED05714464031788 EUDAMED
- Basic UDI-DI
- 57144640-HI-00053-RB EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Air-conduction hearing aid, receiver-in-canal
Bernafon (Lisound) by Sbo Hearing A/S — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57144640-HI-00053-RB | Class IIa | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (4)
- EUDAMED 8d3e2b13-d133-4df2-8478-b45ae345609d 61 fields · synced Jul 25, 2026
- EUDAMED 7446c690-88a6-4908-8c55-8028c9344cb8 61 fields · synced May 16, 2026
- EUDAMED 2b955d3e-1c35-43ae-aee0-08947b7422a8 61 fields · synced May 17, 2026
- EUDAMED 636a16ef-9e79-4da1-9d37-84e8e9871644 61 fields · synced May 19, 2026