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SoniTon UP6 12 R
EUDAMEDClass IIa (EU MDR)
Ref 050-6407-P658Model Sonova RIC hearing aids
by Sonova AG
Identity
- Trade Name
- SoniTon UP6 12 R EUDAMED
- Device Name
- Sonova RIC hearing aids EUDAMED
- Model / Reference
- Sonova RIC hearing aids EUDAMED050-6407-P658 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613389499889 EUDAMED
- Basic UDI-DI
- 07613389RICWJ 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
- Germany 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
SoniTon UP6 12 R by Sonova AG — 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 | 07613389RICWJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonova AG
- EUDAMED SRN
- CH-MF-000015958
- Authorised Representative
- Sonova Deutschland GmbH DE-AR-000006322
Sources (1)
- EUDAMED e5c8a860-3eab-4883-8fc7-b57fa9206900 61 fields · synced Jun 18, 2026