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BlueDot Liver10 IgG

by D-tek s.a. Belgium EUDAMED

Ref LI10D-24Model BlueDot, BlueDot Liver EMDN W0102100703

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-05425023680650 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive
European UnionCE/IVDD NumberB-05425023680650 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BlueDot, LI10D-24, BlueDot Liver
Primary DI / UDI-DI
05425023680650
Basic UDI-DI
B-05425023680650, 542502368BDLIVERBF
Direct Marketing DI
05425023680650
EMDN Code
W0102100703 Lkm1 and related proteins antibodies
Device Class
Class IVD General
Class B
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 f2db5a9f-3c04-4f2d-bf82-9accb319b94b 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023680650|542502368BDLIVERBF 61 fields · synced 18 May 2026