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ViO H428 (pewter)
EUDAMEDClass IIa (EU MDR)
Ref 050-6864-P748Model Sonova BTE hearing aids
by Sonova AG
Identity
- Trade Name
- ViO H428 (pewter) EUDAMED
- Device Name
- Sonova BTE hearing aids EUDAMED
- Model / Reference
- Sonova BTE hearing aids EUDAMED050-6864-P748 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613389750621 EUDAMED
- Basic UDI-DI
- 07613389BTEV7 EUDAMED
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) 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
ViO H428 (pewter) by Sonova AG — 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 | 07613389BTEV7 | 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 c428f1b9-1b90-4969-8713-614b7f7ecc1b 61 fields · synced Jul 18, 2026