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: HI (BTE), HI (ITE), CROS/BI-CROS transmitter, Hearing instrument charger, Fitting Software.
Among these devices, 10 427 are declared active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 427 |
| Country of registration | Denmark |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.