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BlueDot Scleroderma10 IgG

by D-tek s.a. Belgium EUDAMED

Ref SCL10D-24Model BlueDot Scleroderma, BlueDot

EMDN W0102100110

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number542502368BDSCLERODERMAK9 Basic UDI-DIDate13 Nov 2025RegisteredStatusActive
European UnionCE/IVDR Number542502368BDSCLERODERMAK9 Basic UDI-DIDate13 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
BlueDot Scleroderma, SCL10D-24, BlueDot
Primary DI / UDI-DI
05425023680766
Basic UDI-DI
542502368BDSCLERODERMAK9, B-05425023680766
Direct Marketing DI
05425023680766
EMDN Code
W0102100110 Scl-70
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 afd52395-47f5-4e7c-9f86-e827428fe97f 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023680766|B-05425023680766 61 fields · synced 19 May 2026