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FULL ANA Dot

by D-tek s.a. Belgium EUDAMED

Ref AD FULLANAD, AD FULLANADBDModel BlueDot, BlueDiver Dot

EMDN W0102100101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDANAZF Basic UDI-DIDate30 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
FULL ANA Dot
FULL ANA Dot for BDI
Device Name
BlueDot ANA Screening
BlueDiver Dot ANA Screening
Model / Reference
BlueDot, AD FULLANAD, BlueDiver Dot, AD FULLANADBD
Primary DI / UDI-DI
05425023687130, 05425023687437
Basic UDI-DI
542502368BDANAZF, 542502368BDDANAYE
Direct Marketing DI
05425023687130
05425023687437
EMDN Code
W0102100101 Ana screening
Device Class
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 de67dc3b-c4ff-4b06-b770-cd3b53e197c5 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023687437|542502368BDDANAYE 61 fields · synced 19 May 2026