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Unitron Ativo SP (pewter)
EUDAMEDClass IIa (EU MDR)
Ref 050-6902-P7Model Sonova BTE hearing aids
by Sonova AG
Identity
- Trade Name
- Unitron Ativo SP (pewter) EUDAMED
- Device Name
- Sonova BTE hearing aids EUDAMED
- Model / Reference
- Sonova BTE hearing aids EUDAMED050-6902-P7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613389739626 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
Unitron Ativo SP (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 f4ff5d44-7dc9-4c25-bb72-8fd1bb6b7aea 61 fields · synced Jul 23, 2026