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GCAL®NEPH Calibrator

by Gentian AS Norway EUDAMED

Ref 1712Model 1701 EMDN W0102152203

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number9003846B02GCAL003E2 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
GCAL®NEPH Calprotectin
Model / Reference
1701, 1712
Primary DI / UDI-DI
07090038460214
Basic UDI-DI
9003846B02GCAL003E2
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 & raw data

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

Sources (1)

  • EUDAMED 11424188-84a5-4ef0-be8d-35f4f23f6059 61 fields · synced 22 Oct 2026