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Lung cancer-associated gene methylation digital PCR detection kit

by TargetingOne Technology (Beijing) Corporation China EUDAMED

Ref 12916-1Model LM01-Q24

EMDN W01060299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974689626667 Basic UDI-DIDate12 May 2026RegisteredStatusActive

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

Model / Reference
LM01-Q24, 12916-1
Primary DI / UDI-DI
06974689626667
Basic UDI-DI
B-06974689626667
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000028247
Authorised representative
Medunion S.L. ES-AR-000019366

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 b6f6047b-ea13-4eb8-a536-815ddce99f29 61 fields · synced 22 Oct 2026