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Scleroderma Profile 10 Ag Dot for BDI

by D-tek s.a. Belgium EUDAMED

Ref AD SCLERO10DBD, AD SCLERO10DModel BlueDiverDot Scleroderma, BlueDot Scleroderma EMDN W0102100110

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDDSCLERODERMAKH Basic UDI-DIDate24 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  • Withdrawn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 22 Oct 2026

Trade Name
Scleroderma Profile 10 Ag Dot for BDI
Scleroderma Profile 10 Ag Dot
Model / Reference
BlueDiverDot Scleroderma, AD SCLERO10DBD, BlueDot Scleroderma, AD SCLERO10D
Primary DI / UDI-DI
05425023687543, 05425023687246
Basic UDI-DI
542502368BDDSCLERODERMAKH, 542502368BDSCLERODERMAK9
Direct Marketing DI
05425023687543
05425023687246
EMDN Code
W0102100110 Scl-70
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 (2)

  • EUDAMED d9ad260a-8e29-4bcc-834e-ec3a80e04ac3 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023687246|542502368BDSCLERODERMAK9 61 fields · synced 18 May 2026