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HLA Wipe Test

by CareDx AB EUDAMED

Active European Union

Ref 102.101-01uModel Olerup SSP

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07340035508021 Basic UDI-DIDate16 Jun 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  • Withdrawn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
HLA Wipe Test
Model / Reference
Olerup SSP, 102.101-01u
Primary DI / UDI-DI
07340035508021
Basic UDI-DI
B-07340035508021
EMDN Code
W01030403 Hla antigen typing
Device Class
Class IVD General
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000040995

Other devices from CareDx AB

See all devices from CareDx AB →

Properties

  • 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