Phonak Target 11.0 DVD
by Sonova AG
Ref 058-0125-110Model Sonova hearing aid fitting software
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07613389790337 | Date20 May 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number07613389SWAQ 07613389790337 | Date11 Dec 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Phonak Target 11.0 DVD EUDAMEDDVD Phonak Target 11.0 DVD GUDID
- Generic Name
- Audiometric/hearing device software
- Device Name
- Sonova hearing aid fitting software
- Model / Ref / Catalog
- Sonova hearing aid fitting software, 058-0125-110, 11.0 DVD
- Primary DI / UDI-DI
- 07613389790337
- Basic UDI-DI
- 07613389SWAQ
- FDA Product Code
- OSM
- EMDN Code
- Y214599 Hearing aids - other
- GMDN Term
- Audiometric/hearing device software
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 874.3305
- Special Device Type
- Software
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Sonova hearing aid fitting software 058-0125-110 | 11.0 DVD |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CH-MF-000015958
- Authorised representative
- Sonova Deutschland GmbH DE-AR-000006322
Other devices from Sonova AG
Properties
Other properties (21)
- Sterile: No
- Single Use: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No