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Lung Cancer Mutant Genes Detction Panel (Multiplex Real-time PCR)

by Gold Probe Diagnostic Biotechnology Inc. MF China EUDAMED

Ref 600050 EMDN W01060299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975977070506 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Lung Cancer Mutant Genes Detction Panel (Multiplex Real-time PCR)
Model / Reference
600050
Primary DI / UDI-DI
06975977070506
Basic UDI-DI
B-06975977070506
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
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

Other devices from Gold Probe Diagnostic Biotechnology Inc. MF

See all devices from Gold Probe Diagnostic Biotechnology Inc. MF →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED a2e17edd-df3b-48b3-b895-1248a06ed1e2 61 fields · synced 22 Oct 2026