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BlueDiverDot ANCA+GBM IgG

by D-tek s.a. Belgium EUDAMED

Ref ANCAGDIV-24Model BlueDiverDot ANCA, 542502368BDDANCA4F EMDN W0102100401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number542502368BDDANCA4F Basic UDI-DIDate24 Nov 2025RegisteredStatusActive
European UnionCE/IVDR Number542502368BDDANCA4F Basic UDI-DIDate24 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
BlueDiverDot ANCA+GBM IgG
BlueDiver Dot ANCA+GBM IgG
Device Name
BlueDiver Dot ANCA
Model / Reference
BlueDiverDot ANCA, ANCAGDIV-24, 542502368BDDANCA4F
Primary DI / UDI-DI
05425023681350
Basic UDI-DI
542502368BDDANCA4F, B-05425023681350
Direct Marketing DI
05425023681350
EMDN Code
W0102100401 Anca 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 1695349f-a933-4ffd-9423-a358daa4443b 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023681350|B-05425023681350 61 fields · synced 18 May 2026