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astraia – software for women's health

by NEXUS / ASTRAIA GmbH 2 variants

Ref 29.01.00, 29.02.00

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426074885ASTRAIASC Basic UDI-DI Date5 Apr 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
29.01.00, 29.02.00
Primary DI / UDI-DI
04260748850022, 04260748850039
Basic UDI-DI
426074885ASTRAIASC
Direct Marketing DI
04260748850022
04260748850039
EMDN Code
Z12080192 Prenatal diagnostic instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000007042

From the manufacturer

Manufacturer's product page: astraia software for women's health

Other devices from NEXUS / ASTRAIA GmbH

Properties

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No