Easy Line Remote 7.0
by Sonova AG
Ref 07613389759266Model Sonova hearing aid mobile app
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 |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number07613389APPSND 07613389759266 | Date8 Apr 2025 | StatusActive |
| United States | GUDID listing GUDID | Number07613389759266 | Date21 May 2024 | StatusListed |
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- Withdrawn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
- Easy Line Remote 7.0 EUDAMEDEasy Line Remote 7 GUDID
- Generic Name
- Audiometric/hearing device software
- Device Name
- Sonova hearing aid mobile app
- Model / Ref / Catalog
- Sonova hearing aid mobile app EUDAMED07613389759266 EUDAMED7.0 GUDID088-0023-00070 GUDID
- Primary DI / UDI-DI
- 07613389759266
- Basic UDI-DI
- 07613389APPSND
- Direct Marketing DI
- 07613389759266
- FDA Product Code
- OSM
- EMDN Code
- Y214580 Hearing aids or hearing devices - accessories
- 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
- Austria
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Sonova hearing aid mobile app 07613389759266 | 7.0 |
| 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