Lionex GmbH
DE-MF-000038504 · Germany · BRAUNSCHWEIG
Lionex GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- LIODetect® TB-ST
- LIOFeron® TB/LTBI
Catalogue references include 3010_EN, CRP 10-30_10_EN, CRP 10-60_10_EN, D-Dimer_10_EN, LIOFeron 01_22, LIOFeron 02_22.
European nomenclature codes declared: W01030601, W0102160601, W0105090199, W0103020803, W0102160703.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| 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 | 4 |
|---|---|
| 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. Lionex GmbH was not found in either the U.S. or the Canadian register.