Cybergene AB
SE-MF-000054343 · Sweden · Solna
Cybergene AB is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: 136 tests, 26 tests, 68 tests.
Devices declared under this manufacturer
- ChromoQuant STaR Optima 2
Showing 12 of 14 declared devices.
Catalogue references include 513.001-26, 514.100-136, 514.100-68, 514.201-26, 514.601-26, 514.602-26.
European nomenclature codes declared: W0106010399, W0106010306, W0106010301, W0106010302, W0106010304, W010699.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| 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. Cybergene AB was not found in either the U.S. or the Canadian register.