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Human CYP2C9 and VKORC1 Gene Detection Kit (Fluorometric PCR)

by Beijing Applied Biological Technologies Co., Ltd. China EUDAMED

Ref ID014

EMDN W0106030101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974323012818 Basic UDI-DIDate18 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 24 Oct 2026

Device Name
Human CYP2C9 and VKORC1 Gene Detection Kit (Fluorometric PCR)
Model / Reference
ID014
Primary DI / UDI-DI
06974323012818
Basic UDI-DI
B-06974323012818
EMDN Code
W0106030101 Cyp 450 - individual test
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012338
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED c9d917ec-cffa-4477-9ffc-72a5d6e542a9 61 fields · synced 24 Oct 2026