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Release 23SEP2013

by RefLab Aps Denmark EUDAMED

Ref v13-0913, v4.0-0613Model ver 3.0-0612

EMDN W0201020282

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number574400328SOFTWE5 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 24 Oct 2026

Device Name
Software
Model / Reference
ver 3.0-0612, v13-0913, v4.0-0613
Primary DI / UDI-DI
05744003280063, 05744003280049
Basic UDI-DI
574400328SOFTWE5
EMDN Code
W0201020282 Limited panel immunochemistry analysers - software accessories
Device Class
Class A
Special Device Type
Software
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
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 4fe94c41-adec-4e2f-b9d0-ca066870bd5f 61 fields · synced 24 Oct 2026
  • EUDAMED 05744003280049|574400328SOFTWE5 61 fields · synced 18 May 2026