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BlueDiverDot Granular12 IgG

by D-tek s.a. Belgium EUDAMED

Ref GR12DIV-24Model BlueDiver Dot, 542502368BDDGRANULARDB EMDN W0102100112

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDDGRANULARDB Basic UDI-DIDate17 Oct 2025RegisteredStatusActive

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  • Withdrawn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 Granular12 IgG
BlueDiver Dot Granular12 IgG
Device Name
BlueDiverDot Granular IgG
BlueDiver Dot Granular
Model / Reference
BlueDiver Dot, GR12DIV-24, 542502368BDDGRANULARDB
Primary DI / UDI-DI
05425023681824
Basic UDI-DI
542502368BDDGRANULARDB, B-05425023681824
Direct Marketing DI
05425023681824
EMDN Code
W0102100112 Ss-a
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 ad8ffa96-c2b6-4dd2-bf68-bb179c0753ac 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023681824|B-05425023681824 61 fields · synced 18 May 2026