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BlueDot GAD IgG

by D-tek s.a. Belgium EUDAMED

Ref GAD-24Model BlueDot, BlueDot GAD

EMDN W0102100299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05425023680704 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BlueDot, GAD-24, BlueDot GAD
Primary DI / UDI-DI
05425023680704
Basic UDI-DI
B-05425023680704, 542502368BDGADZC
Direct Marketing DI
05425023680704
EMDN Code
W0102100299 Neuro-auto-immune disease - 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 3863e255-3d70-4808-9905-b0649a6eb03d 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023680704|542502368BDGADZC 61 fields · synced 17 May 2026