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astraia FMF - First Trimester Screening for Trisomies

by NEXUS / ASTRAIA GmbH

Ref 05.00.00

Active European Union

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number426074885AST-FMFCW2 Basic UDI-DI 04260748854006UDI-DIDate1 Sep 2026RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
05.00.00
Primary DI / UDI-DI
04260748854006
Basic UDI-DI
426074885AST-FMFCW2
Direct Marketing DI
04260748854006
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class C
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

Other properties (11)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No