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KRAS/NRAS/PIK3CA/BRAF Mutations Detection Kit （Real-time PCR Assays）

by Gold Probe Diagnostic Biotechnology Inc. MF EUDAMED

Active European Union

Ref 600010

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975977070100 Basic UDI-DIDate11 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
KRAS/NRAS/PIK3CA/BRAF Mutations Detection Kit （Real-time PCR Assays）
Model / Reference
600010
Primary DI / UDI-DI
06975977070100
Basic UDI-DI
B-06975977070100
EMDN Code
W01060202 K-ras
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000031524
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

Show properties
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Surgical Instrument: No