Sonova AG
CH-MF-000015958 · Switzerland · Staefa
Sonova AG is registered in the European database on medical devices as a manufacturer, with 3 796 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 3 796 |
|---|
Most frequent device types declared: Sonova BTE hearing aids, Sonova CROS device, Sonova Charging Accessories, Sonova Focus device, Sonova ITE hearing aids.
Among these devices, 3 789 are declared active, 7 with a measuring function.
Authorised representative in the Union: Sonova Deutschland GmbH.
Devices declared under this manufacturer
- Advance 672 R
- AudioNova A-RIC trial
- AudioNova V3-PR (espresso)
- Phonak Audeo I50-R
- Phonak Audéo L30-RL
- Phonak Audéo L30-RT
- Phonak Audéo P70-312
- Phonak Audéo P70-R
- SoniTon UP6 20 R
- Stride B7-PR (sand)
- ampli-energy B 2 L RP PH (sand beige)
- ampli-energy B 5 L RP PH (sand beige)
Showing 12 of 3 796 declared devices.
Catalogue references include 050-1006-Q2, 050-1011-P1, 050-1048-P7, 050-1069-P167, 050-6409-P658, 050-6422-U4.
European nomenclature codes declared: Y2145060102, Y2145060101, Y2145060201, Y214580, Y214599, Z12040192.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Sonova AG (CH) · FDA 3005085999 |
| Devices in EUDAMED | 3 796 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 3 796 |
|---|---|
| Found in the U.S. device database | 2 316 |
| Share | 61.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SONOVA AG |
What it holds in Canada
| Licences on record | 16 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 16 |
| First licensed | 1999-02-19 |
Licence types: Device Family (11), Single Device (3), System (2).
Licensed under: BEHIND THE EAR HEARING AID, IN THE EAR HEARING AID, CHARGER SYSTEMS, REMOTE CONTROL, PHONAK AUDIO INPUT DEVICES, MOBILE APP.
North American profile: Both markets. Sonova AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
38657 | supplemented | 2026-11-08 |