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Unitron TrueFit 5.10
EUDAMEDClass IIa (EU MDR)
Ref 088-5019-000510Model Sonova hearing aid fitting software
by Sonova AG
Identity
- Trade Name
- Unitron TrueFit 5.10 EUDAMED
- Device Name
- Sonova hearing aid fitting software EUDAMED
- Model / Reference
- Sonova hearing aid fitting software EUDAMED088-5019-000510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613389867022 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
Unitron TrueFit 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 79bb0900-ad75-48f7-acb9-49a147281ca5 61 fields · synced Jul 9, 2026