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Human EGFR Gene Mutation Detection Kit (PCR-Fluorescence Method)

by Wuhan YZY Medical Science and Technology Co., Ltd EUDAMED

Active European Union

Ref YZYMT-002-CE

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974604720012 Basic UDI-DIDate23 Jan 2026RegisteredStatusActive

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  • Withdrawn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
Human EGFR Gene Mutation Detection Kit (PCR-Fluorescence Method)
Model / Reference
YZYMT-002-CE
Primary DI / UDI-DI
06974604720012
Basic UDI-DI
B-06974604720012
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000036323
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • Reagent

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No