Unident AB
SE-MF-000004887 · Sweden · Falkenberg
Unident AB is registered in the European database on medical devices as a manufacturer, with 67 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 67 |
|---|
Most frequent device types declared: Sensor holders 200 / 300 / 400 series, Intraoral sensor holder, AnyRay sensor holder, Intraoral sensor protection cover, Onepix.
Among these devices, 1 are declared active, 1 with a measuring function.
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 | 67 |
| Country of registration | Sweden |
⚠️ 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620145488 | issued | 2027-12-16 |