MX Healthcare GmbH
DE-MF-000006986 · Germany · Berlin
MX Healthcare GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 3 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: 1.X, 2.X.
Among these devices, 3 are declared active.
Devices declared under this manufacturer
- Vara AI
- Vara Flux
- Vara MG
- Vara PACS
Catalogue references include 1.X, 2.X.
European nomenclature codes declared: Z11030292, Z11030282.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 5 |
|---|---|
| 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. MX Healthcare GmbH was not found in either the U.S. or the Canadian register.