Skip to content

Gluténérzékenység Gyorsteszt

by PRIMA Lab SA EUDAMED

Active European Union

Ref CE2H88B00KIT01HU

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number764016486CE2H867 Basic UDI-DIDate2 Mar 2026RegisteredStatusActive

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  • Withdrawn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)
  • D1408400113 Supplemented

    Technical documentation EU IVDR

    Notified body
    Notified body 0483
    Issued
    14 Jul 2026
    Expires
    25 Oct 2028
    Reason
    Add device or group

Specification

EUDAMED

Device Name
Celiac Disease Screening Test
Model / Reference
CE2H88B00KIT01HU
Primary DI / UDI-DI
07640164860800
Basic UDI-DI
764016486CE2H867
Direct Marketing DI
07640164860800
EMDN Code
W0102100602 Tissue transglutaminase/ gliadin antibodies combitest
Device Class
Class C
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
CH-MF-000034473
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from PRIMA Lab SA

See all devices from PRIMA Lab SA →

Properties

  • Animal Tissues
  • Microbial Substances
  • Self Testing
  • New Device

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No