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Histareader501

by RefLab Aps Denmark EUDAMED

Ref RLA501Model 501

EMDN W0201020280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number574400328READER8M Basic UDI-DIDate17 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
501, RLA501
Primary DI / UDI-DI
05744003280018
Basic UDI-DI
574400328READER8M
EMDN Code
W0201020280 Limited panel immunochemistry analysers - hardware accessories
Device Class
Class A
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000021844

Other devices from RefLab Aps

See all devices from RefLab Aps →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED bf66f7c6-78a7-4e6c-a036-285e08e2dfa0 61 fields · synced 23 Oct 2026