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: AnyRay sensor holder, Intraoral sensor holder, Intraoral sensor protection cover, Onepix, Sensor holders 200 / 300 / 400 series.
Among these devices, 1 are declared active, 1 with a measuring function.
Devices declared under this manufacturer
- Unident AnyRay sensor holder, size 2
- Unident AnyRay sensor, size 2holder
- Unident Intraoral Sensor Protection Cover
- Unident sensor holder, Anterior edge grip holder
- Unident sensor holder, Anterior periapical holder size 1
- Unident sensor holder, Horizontal apical, size 2, short
- Unident sensor holder, Horizontal bitewing, blue
- Unident sensor holder, Intro kit holder size 0, mini
- Unident sensor holder, Posterior periapical holder size 1
- Unident sensor holder, Posterior periapical holder size 2
- Unident sensor holder, SnapBite vertical bitewing, size 0
- Unident sensor holder, SnapBite vertical bitewing, size 1
Showing 12 of 67 declared devices.
Catalogue references include 357300, 357601, A222, A270, A302P, A441.
European nomenclature codes declared: Q0199, T030199, Z110603.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 67 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 67 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Unident AB was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620145488 | issued | 2027-12-16 |