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Droplex PIK3CA Mutation Test

by Gencurix, Inc. South Korea EUDAMED

Ref CD006

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800087700143 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CD006
Primary DI / UDI-DI
08800087700143
Basic UDI-DI
B-08800087700143
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
Market of Registration
Bulgaria

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
  • Companion Diagnostics
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 4e8937d7-07cf-496f-8cb3-b2a5c9b9d23c 61 fields · synced 22 Oct 2026