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Gentian GCAL® Calprotectin Calibrator Kit

by Gentian AS EUDAMED

Active European Union

Ref 1251Model 1201

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number9003846B02GCAL002DY Basic UDI-DIDate21 Oct 2021RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Gentian Calprotectin Reagent Kit
Model / Reference
1201, 1251
Primary DI / UDI-DI
07090038460191
Basic UDI-DI
9003846B02GCAL002DY
Direct Marketing DI
07090038460191
EMDN Code
W0102152203 Specific protein standards and calibrators
Device Class
Class B
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
NO-MF-000003448

Other devices from Gentian AS

See all devices from Gentian AS →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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