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Aura:fit 5.10
EUDAMEDClass IIa (EU MDR)
Ref 058-5180-0510Model Sonova hearing aid fitting software
by Sonova AG
Identity
- Trade Name
- Aura:fit 5.10 EUDAMED
- Device Name
- Sonova hearing aid fitting software EUDAMED
- Model / Reference
- Sonova hearing aid fitting software EUDAMED058-5180-0510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613389867046 EUDAMED
- Basic UDI-DI
- 07613389SWAQ EUDAMED
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Aura:fit 5.10 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 | 07613389SWAQ | 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 969917ce-064a-4bb6-9b51-66743d7f5aa3 61 fields · synced Jul 23, 2026