Identity
- Trade Name
- SoniTon EUDAMED
- Model / Reference
- HI (ITE) EUDAMED248726 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464063307 EUDAMED
- Basic UDI-DI
- 57144640-HI-00076-RW EUDAMED
- EMDN Code
- Y2145060204 HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC) 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
SoniTon 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-HI-00076-RW | Class IIa | Active |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (1)
- EUDAMED af46bb53-32c1-4c3f-af74-dadac268ea81 61 fields · synced May 29, 2026