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BlueDot ASCA IgG + IgA

by D-tek s.a. Belgium EUDAMED

Ref ASCCD-24Model BlueDot ASCA, BlueDot

EMDN W0102100801

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number542502368BDCROHN99 Basic UDI-DIDate18 Nov 2025RegisteredStatusActive
European UnionCE/IVDR Number542502368BDCROHN99 Basic UDI-DIDate18 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

Model / Reference
BlueDot ASCA, ASCCD-24, BlueDot
Primary DI / UDI-DI
05425023680377
Basic UDI-DI
542502368BDCROHN99, B-05425023680377
Direct Marketing DI
05425023680377
EMDN Code
W0102100801, W0102109018
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 db16ac81-2a07-44bf-bd6a-5bfd9281201d 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023680377|B-05425023680377 61 fields · synced 19 May 2026