SoniTon UP Basic 2.0 UP (platinum)
by Sonova AG
Ref 050-6903-P658Model Sonova BTE hearing aids
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number07613389BTEV7 07613389739503 | Date21 Aug 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sonova BTE hearing aids
- Model / Reference
- Sonova BTE hearing aids, 050-6903-P658
- Primary DI / UDI-DI
- 07613389739503
- Basic UDI-DI
- 07613389BTEV7
- EMDN Code
- Y2145060101 Behind-the-ear hearing aids with receiver in the device (bte)
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000015958
- Authorised representative
- Sonova Deutschland GmbH DE-AR-000006322
Other devices from Sonova AG
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No