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Sbo
EUDAMEDClass I (EU MDR)
Ref 142207Model DAI AdapterRef 142328Model FM Adapter
Identity
- Trade Name
- SBO EUDAMED
- Model / Reference
- DAI Adapter EUDAMED142207 EUDAMEDFM Adapter EUDAMED142328 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05707131279545 EUDAMED05707131274618 EUDAMED
- Basic UDI-DI
- 57144640-DAIA-00046-N4 EUDAMED57144640-FMA-00043-9X EUDAMED
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Sbo by Sbo Hearing A/S — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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-DAIA-00046-N4 | Class I | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (2)
- EUDAMED dc9c137a-2293-4966-b236-4552b4d1e6b3 61 fields · synced Aug 2, 2026
- EUDAMED 9b2d9700-8377-4fec-9b43-4f5867021dc1 61 fields · synced May 19, 2026