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Clean Plasma cfDNA Kit Dx

by CleanNA B.V. Netherlands EUDAMED

Ref CPCF2Dx-D0096Model CPCF2Dx EMDN W010699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number87202998087CPCF6B Basic UDI-DIDate28 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Clean Plasma cfDNA Kit 1-2mL Dx
Model / Reference
CPCF2Dx, CPCF2Dx-D0096
Primary DI / UDI-DI
08720299808782
Basic UDI-DI
87202998087CPCF6B
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000022870

From the manufacturer

Manufacturer's product page: Clean Plasma cfDNA Kit

Other devices from CleanNA B.V.

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
  • New Device
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 08720299808782|87202998087CPCF6B 61 fields · synced 24 Oct 2026