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BlueDiver Dot PRL12 IgG

by D-tek s.a. Belgium EUDAMED

Ref PRL12DIV-24Model 542502368BDDANAYE, BlueDiver Dot EMDN W0102100111

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-05425023681794 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive
European UnionCE/IVDD NumberB-05425023681794 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
BlueDiver Dot PRL12 IgG
BlueDiverDot PRL12 IgG
Device Name
BlueDiver Dot ANA
BlueDiver Dot ANA Screening
Model / Reference
542502368BDDANAYE, PRL12DIV-24, BlueDiver Dot
Primary DI / UDI-DI
05425023681794
Basic UDI-DI
B-05425023681794, 542502368BDDANAYE
Direct Marketing DI
05425023681794
EMDN Code
W0102100111 Sm
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 c839442a-2a44-41cf-b4be-630a6c1d1215 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023681794|542502368BDDANAYE 61 fields · synced 18 May 2026