Europea i Malmö AB
SE-MF-000016900 · Sweden · Malmö
Europea i Malmö AB is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 15 |
|---|
Among these devices, 14 are declared active.
Devices declared under this manufacturer
- TERA-Mobile Android
- TERA-Mobile iOS
- TERA-Touch Android
- TERA-Touch iPadOS
- TM-Alert
- TM-MC
- TM-Mobile Android
- TM-Mobile iOS
- TM-PC FF
- TM-PC PRO
- TM-PC STD
- TM-Touch Android
Showing 12 of 15 declared devices.
Catalogue references include TERA-Mobile Android, TERA-Touch Android, TERA-Touch iPadOS, TM-Alert, TM-MC, TM-Mobile Android.
European nomenclature codes declared: Y213699,Y2199, Y211599,Y213699,Y214212,Y2199, Y213699,Y215199,Y2199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 15 |
| 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 | 15 |
|---|---|
| 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. Europea i Malmö AB was not found in either the U.S. or the Canadian register.