Skip to content

BlueDiver Dot Scleroderma10 IgG

by D-tek s.a. Belgium EUDAMED

Ref SCL10DIV-24Model 542502368BDDSCLERODERMAKH, BlueDiverDot Scleroderma

EMDN W0102100110

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-05425023681725 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive
European UnionCE/IVDD NumberB-05425023681725 Basic UDI-DIDate9 Aug 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
BlueDiver Dot Scleroderma10 IgG
BlueDiverDot Scleroderma10 IgG
Device Name
BlueDiver Dot Scleroderma
Model / Reference
542502368BDDSCLERODERMAKH, SCL10DIV-24, BlueDiverDot Scleroderma
Primary DI / UDI-DI
05425023681725
Basic UDI-DI
B-05425023681725, 542502368BDDSCLERODERMAKH
Direct Marketing DI
05425023681725
EMDN Code
W0102100110 Scl-70
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 2486af9c-a3af-43f6-8afd-c3866f9d39da 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023681725|542502368BDDSCLERODERMAKH 61 fields · synced 18 May 2026