mediaire GmbH
DE-MF-000010713 · Germany · Berlin
mediaire GmbH is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 9 |
|---|
Most frequent device types declared: mdbrain, mdknee, mdprostate.
Among these devices, 3 are declared active.
Devices declared under this manufacturer
- mdbrain - app
- mdbrain - cluster&cloud
- mdbrain - standalone
- mdknee - app
- mdknee - cluster&cloud
- mdknee - standalone
- mdprostate - app
- mdprostate - cluster&cloud
- mdprostate - standalone
Catalogue references include 001, 002, 003, 004, 006, 007.
European nomenclature codes declared: Z11059092.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| 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 | 9 |
|---|---|
| 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. mediaire GmbH was not found in either the U.S. or the Canadian register.