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Human B-raf Gene V600E Mutation Detection Kit (Fluorescence PCR Method)

by Wuxi Ruiqi Gene Biotechnology Co., Ltd. China EUDAMED

Ref P111H

EMDN W01060214

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974870710113 Basic UDI-DIDate26 Sep 2022RegisteredStatusActive

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

Device Name
Human B-raf Gene V600E Mutation Detection Kit (Fluorescence PCR Method)
Model / Reference
P111H
Primary DI / UDI-DI
06974870710113
Basic UDI-DI
B-06974870710113
EMDN Code
W01060214 Colorectal cancer (msi-h / dmmr)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000027697
Authorised representative
Lotus NL B.V. NL-AR-000000121

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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 53cd74ee-dfc2-4410-9a1d-cf9bca46c80d 61 fields · synced 22 Oct 2026