mentalis GmbH
DE-MF-000006214 · Germany · 90443
mentalis GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 7 |
|---|
Among these devices, 3 are declared active.
Catalogue references include mentalis Appstinence, mentalis CareNow, mentalis InBalance, mentalis MyJourney, mentalis Phoenix, mentalis ReConnect.
European nomenclature codes declared: Z12040292.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 7 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| 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. mentalis GmbH was not found in either the U.S. or the Canadian register.