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BlueDiverDot ENA6 IgG

by D-tek s.a. Belgium EUDAMED

Ref ENADIV-24Model BlueDiver Dot, 542502368BDDANAYE EMDN W0102100102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDDANAYE Basic UDI-DIDate23 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
BlueDiverDot ENA6 IgG
BlueDiver Dot ENA6 IgG
Device Name
BlueDiver Dot ANA Screening
BlueDiver Dot ANA
Model / Reference
BlueDiver Dot, ENADIV-24, 542502368BDDANAYE
Primary DI / UDI-DI
05425023681442
Basic UDI-DI
542502368BDDANAYE, B-05425023681442
Direct Marketing DI
05425023681442
EMDN Code
W0102100102 Ena screening
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 8641dfb1-8f2f-4d54-8358-c57b06cedefa 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023681442|B-05425023681442 61 fields · synced 17 May 2026