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Ha Vio E428 Li Gnt
EUDAMEDClass IIa (EU MDR)
Ref 10998641Model BTE
by Wsaud A/S
Identity
- Trade Name
- HA VIO E428 LI GNT EUDAMED
- Model / Reference
- BTE EUDAMED10998641 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714880118025 EUDAMED
- Basic UDI-DI
- 5714880-WSA-25-10-37 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
Ha Vio E428 Li Gnt by Wsaud A/S — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Air-conduction hearing aid, behind-the-ear.
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- HHM — Oticon A/S · 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 | 5714880-WSA-25-10-37 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (1)
- EUDAMED c9cf6cd8-7130-46d0-85be-1d387723bd82 61 fields · synced Jul 26, 2026