Cube Dx GmbH
AT-MF-000013909 · Austria · St. Valentin
Cube Dx GmbH is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: GINA 500, PE-Buffer, hyborg Dx RED2.
Devices declared under this manufacturer
- GINA 500
- GINA 500 + DNA purification
- IPC
- LINA
- PCR-Box Bacteria
- PCR-Box Bacteria 48rx-s
- PCR-Box Fungi 48rx-s
- PCR-Box IPC
- PCR-Box Resistance
- PE-Buffer
- Waste Bottle
- hybcell Bacteria DNA xB
Showing 12 of 20 declared devices.
Catalogue references include 09120127730015, 09120127730046, 09120127730060, 09120127730114, 09120127730138, 09120127730152.
European nomenclature codes declared: W0105070203, W02050106, W02050285, W0105080808, W02050201.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 20 |
| Country of registration | Austria |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| 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. Cube Dx GmbH was not found in either the U.S. or the Canadian register.