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BlueDiver Dot Chromatin IgG

by D-tek s.a. Belgium EUDAMED

Ref CHRDIV-24Model 542502368BDDCHROMATIN6Y, BlueDiver Dot

EMDN W0102100107

Regulatory status

as of 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05425023681398 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
BlueDiver Dot Chromatin IgG
BlueDiverDot Chromatin IgG
Device Name
BlueDiver Dot Chromatin
Model / Reference
542502368BDDCHROMATIN6Y, CHRDIV-24, BlueDiver Dot
Primary DI / UDI-DI
05425023681398
Basic UDI-DI
B-05425023681398, 542502368BDDCHROMATIN6Y
Direct Marketing DI
05425023681398
EMDN Code
W0102100107 Histones (h1, h2a, h3, h4,…hn)
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 bc591d75-11d5-4626-90b3-a330b27b651e 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023681398|542502368BDDCHROMATIN6Y 61 fields · synced 17 May 2026