SBO Hearing A/S
DK-MF-000001270 · Denmark · Smørum
SBO Hearing A/S is registered in the European database on medical devices as a manufacturer, with 10 427 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 427 |
|---|
Most frequent device types declared: CROS/BI-CROS transmitter, DAI Adapter, Fitting Software, Fitting device, HI (BTE).
Among these devices, 10 427 are declared active.
Devices declared under this manufacturer
- AGXO
- Amplifon
- Audika
- Bernafon
- GPL
- HHM
- KIND
- Maico
- MicroAudio
- Multisound
- Oticon
- Philips
Showing 12 of 10 427 declared devices.
Catalogue references include 238008, 240302, 240628, 248285, 270036, 280008.
European nomenclature codes declared: Y2145060102, Y2145060101, Y2145060203, Y2145060204, Y2145060201, Y2145060202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 427 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 10 427 |
|---|---|
| Found in the U.S. device database | 3 200 |
| Share | 30.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SBO HEARING A/S |
What it holds in Canada
| Licences on record | 8 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| First licensed | 2019-03-21 |
Licence types: Device Family (8).
Licensed under: IN-THE-EAR-HEARING AIDS, FITTING SOFTWARE, REMOTE CONTROL APPS, TRANSMITTER, ONEAPP, BEHIND-THE-EAR-HEARING AIDS.
North American profile: Canada only. SBO Hearing A/S holds a Canadian licence but was not found in the U.S. register.