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BlueDiverDot Liver5 IgG

by D-tek s.a. Belgium EUDAMED

Ref LISDIV-24Model BlueDiverDot Liver, 542502368BDDLIVERKL

EMDN W0102100703

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number542502368BDDLIVERKL Basic UDI-DIDate24 Nov 2025RegisteredStatusActive
European UnionCE/IVDR Number542502368BDDLIVERKL Basic UDI-DIDate24 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
BlueDiverDot Liver5 IgG
BlueDiver Dot Liver5 IgG
Device Name
BlueDiver Dot Liver
Model / Reference
BlueDiverDot Liver, LISDIV-24, 542502368BDDLIVERKL
Primary DI / UDI-DI
05425023681497
Basic UDI-DI
542502368BDDLIVERKL, B-05425023681497
Direct Marketing DI
05425023681497
EMDN Code
W0102100703 Lkm1 and related proteins antibodies
Device Class
Class B
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000024530

Other devices from D-tek s.a.

See all devices from D-tek s.a. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 3ba66fbc-c341-40c3-9496-49cfca957347 61 fields · synced 22 Oct 2026
  • EUDAMED 38d0979f-e60b-46c9-bdc6-2104bd354122 61 fields · synced 17 May 2026