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Sclero-Poly- Synthetase Profile 12 Ag Dot

by D-tek s.a. Belgium EUDAMED

Ref AD SPS12DModel BlueDot Polymyositis/Scleroderma EMDN W0102100108

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDPMSCLCN Basic UDI-DIDate13 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  • Withdrawn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 24 Oct 2026

Model / Reference
BlueDot Polymyositis/Scleroderma, AD SPS12D
Primary DI / UDI-DI
05425023687277
Basic UDI-DI
542502368BDPMSCLCN
Direct Marketing DI
05425023687277
EMDN Code
W0102100108 Jo-1
Device Class
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 (1)

  • EUDAMED be786b80-5691-434c-a8a3-6f5180ce22a6 61 fields · synced 24 Oct 2026