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Human K-ras Gene Mutation Detection Kit (PCR-Melting Curve Method)

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

Ref P112H

EMDN W01060202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974870710120 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 K-ras Gene Mutation Detection Kit (PCR-Melting Curve Method)
Model / Reference
P112H
Primary DI / UDI-DI
06974870710120
Basic UDI-DI
B-06974870710120
EMDN Code
W01060202 K-ras
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

Other devices from Wuxi Ruiqi Gene Biotechnology Co., Ltd.

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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 ce618b0a-fac7-4f65-a940-2b825137e397 61 fields · synced 22 Oct 2026