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ViO H428 (sand)
EUDAMEDClass IIa (EU MDR)
Ref 050-6864-R848Model Sonova BTE hearing aids
by Sonova AG
Identity
- Trade Name
- ViO H428 (sand) EUDAMED
- Device Name
- Sonova BTE hearing aids EUDAMED
- Model / Reference
- Sonova BTE hearing aids EUDAMED050-6864-R848 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613389750867 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
Category: Air-conduction hearing aid, behind-the-ear
ViO H428 (sand) by Sonova AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
- Oticon — Oticon A/S · Class II
- Phonak — Phonak, Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- HHM — Oticon A/S · Class II
- Signia — WS Audiology USA, Inc. · Class II
- Hansaton — Hansaton Akustik GmbH · Class II
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 4828a36e-0c30-463a-80d0-66e5558a6655 61 fields · synced Jul 23, 2026