Medema A/S
DK-MF-000000981 · Denmark · Herning
Medema A/S is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 30 |
|---|
Most frequent device types declared: 4Front2 Lowrider, Q6 Edge Lowrider, X1- Model, X2-Model.
Among these devices, 28 are declared active.
Devices declared under this manufacturer
- Model X1 3W Black metallic, 10 km/h
- Model X1 4W HD Copper orange metallic 10 km/h
- Model X1 4W w/o seat Black metallic, 10 km/h
- Model X1 4W w/o seat Copper orange metallic, 10 km/h
- Model X1 4W w/o seat Copper orange metallic, 13 km/h
- Model X1 Cabin Copper orange metallic 13 km/h
- Model X2 3W Black metallic 13 km/h
- Model X2 3W Copper orange metallic 13 km/h
- Model X2 4W Copper orange metallic, 13 km/h
- Model X2 4W HD Black metallic, 10 km/h
- Model X2 4W w/o seat Black metallic, 10 km/h
- Model X2 4W w/o seat Copper orange metallic, 13 km/h
Showing 12 of 30 declared devices.
Catalogue references include 1500-1028, 1500-1030, 1500-1035, 1500-1036, 1500-1039, 1500-1081.
European nomenclature codes declared: Y122124, Y122127.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 30 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 30 |
|---|---|
| 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. Medema A/S was not found in either the U.S. or the Canadian register.