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BlueDot ENA6 IgG

by D-tek s.a. Belgium EUDAMED

Ref ENAD-24Model BlueDot

EMDN W0102100102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-05425023680414 Basic UDI-DIDate8 Aug 2024RegisteredStatusActive
European UnionCE/IVDD NumberB-05425023680414 Basic UDI-DIDate8 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

Device Name
BlueDot ANA Screening
Model / Reference
BlueDot, ENAD-24
Primary DI / UDI-DI
05425023680414
Basic UDI-DI
B-05425023680414, 542502368BDANAZF
Direct Marketing DI
05425023680414
EMDN Code
W0102100102 Ena screening
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 a1994d19-6432-4936-a339-10f76ee4c2fd 61 fields · synced 22 Oct 2026
  • EUDAMED b106a6ec-d5b9-4b9b-bbc4-a5606e204e09 61 fields · synced 19 May 2026