Identity
- Trade Name
- Oticon EUDAMED
- Model / Reference
- OneApp EUDAMED285018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464168019 EUDAMED
- Basic UDI-DI
- 57144640-ONEAPP-00085-KJ EUDAMED
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Oticon by Sbo Hearing A/S — Class IIa — 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-ONEAPP-00085-KJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (1)
- EUDAMED 206fec43-1763-46f4-93d4-c197f0e87c61 61 fields · synced May 21, 2026