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EarlyCDT Lung Test Kit

by Freenome Ltd United Kingdom EUDAMED

Ref ECDTL2

EMDN W0102030199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506088522ECDTL26B Basic UDI-DIDate17 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
ECDTL2
Primary DI / UDI-DI
50608852200668
Basic UDI-DI
506088522ECDTL26B
EMDN Code
W0102030199 Cancer antigens - other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
UK-MF-000039593
Authorised representative
qtec EuRep GmbH DE-AR-000005327

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 10c15776-4818-478a-9e88-2ad5dc396d0f 61 fields · synced 22 Oct 2026