Skip to content

Droplex BRAF Mutation Test

by Gencurix, Inc. South Korea EUDAMED

Ref CD005

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number88000877BRV0CD00565 Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CD005
Primary DI / UDI-DI
08800087700075
Basic UDI-DI
88000877BRV0CD00565
EMDN Code
W010699 Genetic tests - other
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 2157c687-a35a-4f7c-abb0-ddc688483d27 61 fields · synced 24 Oct 2026