NEXUS / ASTRAIA GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000007042
- Devices
- 6
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What NEXUS / ASTRAIA GmbH makes
NEXUS / ASTRAIA GmbH makes software for women's health, specifically an obstetric and gynaecological database application known as astraia. This product is designed for documentation of examinations in obstetrics and gynaecology, supporting clinical workflows through a digital platform available in multiple languages.
The astraia software is classified as a Class IIa medical device and is listed in the EUDAMED registry. The company is based in Germany (DE).
Catalogue
- Regimes: CE MDR Registry: EUDAMED
astraia neon Ref 1.0.x
Regimes: CE MDR Registry: EUDAMED- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE IVDR Registry: EUDAMED
astraia – software for women's health - obstetric and gynaecological database application Ref 29.00.00
Regimes: CE MDR Registry: EUDAMEDastraia – software for women's health Ref 29.01.00
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- DE-MF-000007042
- EU VAT number
- DE209125093
- EUDAMED status
- Active
- EUDAMED registered name
- NEXUS / ASTRAIA GmbH
- Registered address
- 80, Adalperostraße, 85737, Ismaning, Germany
- Website
- www.nexus-astraia.com/
- facebook.com/astraiasoftware
- [email protected]
- Phone
- +49 89 127 1147-0
- PRRC contact
- Uwe Hannemann
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 13 Oct 2027
mdc medical device certification GmbH 0483 1 certificate
- D1165200027 Expiring
Quality management system EU MDR
- Issued
- 14 Oct 2026
- Expires
- 13 Oct 2027
- Reason
- Add device or group
From the company website
Astraia software for women’s health offers a cutting-edge OB/GYN software. Supported by leading experts from all over the world we guarantee a comprehensive, practical and efficient documentation of the examinations based on the latest knowledge in around 20 languages.
Frequently asked questions
How many devices does NEXUS / ASTRAIA GmbH have in the registry?
The registry currently lists 6 devices for NEXUS / ASTRAIA GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list NEXUS / ASTRAIA GmbH's devices?
Among its 6 most recently registered devices, NEXUS / ASTRAIA GmbH has devices listed in EUDAMED (6 devices).
What risk classes do NEXUS / ASTRAIA GmbH's devices fall under?
Among its 6 most recently registered devices, the classes recorded for NEXUS / ASTRAIA GmbH's devices are Class IIa, Class IIb and IVDR Class C. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for NEXUS / ASTRAIA GmbH?
EUDAMED lists 1 certificate for NEXUS / ASTRAIA GmbH (quality management system) under MDR. The most recent was issued on 14 Oct 2026.
What are the newest devices from NEXUS / ASTRAIA GmbH in the registry?
The most recently registered devices listed for NEXUS / ASTRAIA GmbH include NEXUS / GEBURTSHILFE CTG-Überwachung (ARGUS), astraia neon, astraia – software for women's health and astraia FMF - First Trimester Screening for Trisomies.