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Reagent kit

by RefLab Aps Denmark EUDAMED

Ref RLA700

EMDN W0201020285

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number574400328REAGK8U Basic UDI-DIDate18 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Reagent kit
Model / Reference
RLA700
Primary DI / UDI-DI
05744003280117
Basic UDI-DI
574400328REAGK8U
EMDN Code
W0201020285 Limited panel immunochemistry analysers - consumables
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED c409ff29-c14b-4ccd-92b5-f97cd7e7e8ee 61 fields · synced 22 Oct 2026