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FetoGnost® Kit RHD

by Ingenetix GmbH Austria EUDAMED

Ref HUFG500 EMDN W0106010499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberITDA/00005/0v001 Date3 Mar 2026IssuedStatusActive expires 2 Mar 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • ITDA/00005/0v001 Issued

    Technical documentation EU IVDR

    Notified body
    QMD Services GmbH 2962
    Issued
    3 Mar 2026
    Expires
    2 Mar 2031

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
HUFG500
Primary DI / UDI-DI
09120110506405
Basic UDI-DI
912011050HUFGRXX8D
Direct Marketing DI
09120110506405
EMDN Code
W0106010499 Polymorphism tests - other
Device Class
Class D
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000001501

Other devices from Ingenetix GmbH

See all devices from Ingenetix GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 6f58d72b-6eb0-4c76-a87f-8151f075f617 61 fields · synced 23 Oct 2026