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BlueDot APS IgG

by D-tek s.a. Belgium EUDAMED

Ref APSGD-24Model BlueDot, BlueDot APS

EMDN W0102100599

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-05425023680360 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive
European UnionCE/IVDD NumberB-05425023680360 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BlueDot, APSGD-24, BlueDot APS
Primary DI / UDI-DI
05425023680360
Basic UDI-DI
B-05425023680360, 542502368BDAPS2U
Direct Marketing DI
05425023680360
EMDN Code
W0102100599 Anti-phospholip syndrome - other
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 9eae117d-d26c-4bce-8e7f-408dd3e57d93 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023680360|542502368BDAPS2U 61 fields · synced 19 May 2026