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BlueDot Polymyositis/Scleroderma8 IgG

by D-tek s.a. Belgium EUDAMED

Ref PMS8D-24Model BlueDot, BlueDot Polymyositis/Scleroderma EMDN W0102100108

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05425023680551 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BlueDot, PMS8D-24, BlueDot Polymyositis/Scleroderma
Primary DI / UDI-DI
05425023680551
Basic UDI-DI
B-05425023680551, 542502368BDPMSCLCN
Direct Marketing DI
05425023680551
EMDN Code
W0102100108 Jo-1
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 fdff7580-e470-4902-b04e-1a4672cf3360 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023680551|542502368BDPMSCLCN 61 fields · synced 19 May 2026