inno-train Diagnostik GmbH
DE-MF-000024702 · Germany · Kronberg
inno-train Diagnostik GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Devices declared under this manufacturer
- FluoVista System
- HLA-Ready Gene B27
- HLA-Ready Gene B57
- HLA-Ready Gene Coeliac Disease
- HPA-FluoGene 1a/b Screen
- HPA-FluoGene NX
- RBC-FluoGene ABO basic
- RBC-Ready Gene ABO
Catalogue references include 001 010 012, 001 086 010, 001 086 040, 002 058 032, 002 061 032, 003 015 010.
European nomenclature codes declared: W0106010499, W010699, W0299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| 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 | 11 |
|---|---|
| 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. inno-train Diagnostik GmbH was not found in either the U.S. or the Canadian register.