NEXUS / ASTRAIA GmbH
DE-MF-000007042 · Germany · Ismaning
NEXUS / ASTRAIA GmbH is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Among these devices, 6 are declared active, 5 with a measuring function.
Devices declared under this manufacturer
- astraia neon
- astraia – software for women's health
- astraia – software for women's health - obstetric and gynaecological d
Catalogue references include 1.0.x, 1.27.4, 29.00.00, 29.01.00, 29.02.00, 30.00.xx, 30.01.xx.
European nomenclature codes declared: Z12080192.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| 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 | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NEXUS / ASTRAIA GMBH |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| First licensed | 2012-02-07 |
Licence types: Single Device (1).
Licensed under: ASTRAIA - SOFTWARE FOR WOMEN`S HEALTH.
North American profile: Canada only. NEXUS / ASTRAIA GmbH holds a Canadian licence but was not found in the U.S. register.