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Vitamin D xPOC

by GENSPEED Biotech Austria EUDAMED

Ref IATK215

EMDN W01021699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number912013177VitaminD3CJ Basic UDI-DIDate12 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • ITDA/00002/0v003 Issued

    Technical documentation EU IVDR

    Notified body
    QMD Services GmbH 2962
    Issued
    22 Jan 2026
    Expires
    4 Sep 2029

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
IATK215
Primary DI / UDI-DI
09120131770021
Basic UDI-DI
912013177VitaminD3CJ
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
Device Class
Class B
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000013008

Other devices from GENSPEED Biotech

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 240fe66d-57d6-424a-ae98-ff8b7bb4d793 61 fields · synced 22 Oct 2026