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Droplex KRAS Mutation Test v3

by Gencurix, Inc. South Korea EUDAMED

Ref CD021

EMDN W01060202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88000877KRV3CD021DR Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CD021
Primary DI / UDI-DI
08800087700181
Basic UDI-DI
88000877KRV3CD021DR
EMDN Code
W01060202 K-ras
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000034097
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Gencurix, Inc.

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 4af6827d-71c0-4099-bbcd-d610a09f4016 61 fields · synced 22 Oct 2026