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Sclero-Poly- Synthetase Profile 12 Ag Dot for BDI

by D-tek s.a. EUDAMED

Active European Union

Ref AD SPS12DBDModel BlueDiverDot Polymyositis/Scleroderma

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDDPMSCLLT 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  • Withdrawn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

Model / Reference
BlueDiverDot Polymyositis/Scleroderma, AD SPS12DBD
Primary DI / UDI-DI
05425023687574
Basic UDI-DI
542502368BDDPMSCLLT
Direct Marketing DI
05425023687574
EMDN Code
W0102100108 Jo-1
Device Class
Class B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000024530

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See all devices from D-tek s.a. →

Properties

  • 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