DiaMex GmbH
DE-MF-000037219 · Germany · Heidelberg
DiaMex GmbH is registered in the European database on medical devices as a manufacturer, with 65 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: No, Optitrol Blue, Optitrol Green, Optitrol Red, Optitrol Yellow.
Devices declared under this manufacturer
- Optitrol Blue
- Optitrol Green
- Optitrol HEPA-2
- Optitrol HEPR-2
- Optitrol HIV 2
- Optitrol HIVp24
- Optitrol NAT HBV Viral Load
- Optitrol NAT HCV Viral Load
- Optitrol NAT HEV
- Optitrol NAT HIV Screening
- Optitrol NAT Triplex
- Optitrol Red
Showing 12 of 65 declared devices.
Catalogue references include NT01024, NT01032, NT01122, SR11000, SR11021, SR11023.
European nomenclature codes declared: W0105080807, W0105080808, W0105080899, W0105080803.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 65 |
| 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 | 65 |
|---|---|
| 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. DiaMex GmbH was not found in either the U.S. or the Canadian register.