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AlloSeq cfDNA

by CareDx AB EUDAMED

Active European Union

Ref 505.101-24Model AlloSeq cfDNA

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number73400355ASCFJ5 Basic UDI-DIDate29 Sep 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  • Withdrawn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

Device Name
AlloSeq cfDNA
Model / Reference
AlloSeq cfDNA, 505.101-24
Primary DI / UDI-DI
07340035528005
Basic UDI-DI
73400355ASCFJ5
Direct Marketing DI
07340035528005
EMDN Code
W0106010499 Polymorphism tests - other
Device Class
Class C
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000040995

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See all devices from CareDx AB →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No