Skip to content

BlueDiverDot ANA + DFS-70 IgG

by D-tek s.a. Belgium EUDAMED

Ref RLH12DIV-24Model BlueDiver Dot, 542502368BDDANAYE EMDN W0102100101

Regulatory status

as of 26 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  • Withdrawn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 ANA + DFS-70 IgG
BlueDiver Dot ANA + DFS-70 IgG
Device Name
BlueDiver Dot ANA Screening
BlueDiver Dot ANA
Model / Reference
BlueDiver Dot, RLH12DIV-24, 542502368BDDANAYE
Primary DI / UDI-DI
05425023681695
Basic UDI-DI
542502368BDDANAYE, B-05425023681695
Direct Marketing DI
05425023681695
EMDN Code
W0102100101 Ana 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 6ddf2ee1-ebd7-4d6b-9ddb-0a29899cb256 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023681695|B-05425023681695 61 fields · synced 18 May 2026