Skip to content

BlueDiverDot Myositis12 SAE IgG

by D-tek s.a. Belgium EUDAMED

Ref MYOS12DIV-24Model BlueDiverDot Myositis, 542502368BDDMYOSITISTF EMDN W0102100108

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDDMYOSITISTF Basic UDI-DIDate18 Nov 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  • Withdrawn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 Myositis12 SAE IgG
BlueDiver Dot Myositis12 SAE IgG
Device Name
BlueDiver Dot Myositis
Model / Reference
BlueDiverDot Myositis, MYOS12DIV-24, 542502368BDDMYOSITISTF
Primary DI / UDI-DI
05425023681763
Basic UDI-DI
542502368BDDMYOSITISTF, B-05425023681763
Direct Marketing DI
05425023681763
EMDN Code
W0102100108 Jo-1
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 e03eab65-c82a-4be0-b651-1daaefb31766 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023681763|B-05425023681763 61 fields · synced 18 May 2026