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Myositis Profile 12 Ag Dot

by D-tek s.a. Belgium EUDAMED

Ref AD MYOS12AD, AD MYOS12ADBDModel BlueDot Myositis, BlueDiverDot Myositis EMDN W0102100108

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDMYOSITIS74 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  • Withdrawn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 22 Oct 2026

Trade Name
Myositis Profile 12 Ag Dot
Myositis Profile 12 Ag Dot for BDI
Model / Reference
BlueDot Myositis, AD MYOS12AD, BlueDiverDot Myositis, AD MYOS12ADBD
Primary DI / UDI-DI
05425023687208, 05425023687505
Basic UDI-DI
542502368BDMYOSITIS74, 542502368BDDMYOSITISTF
Direct Marketing DI
05425023687208
05425023687505
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 (2)

  • EUDAMED 522c9296-0939-4df4-8f85-4d51114458e6 61 fields · synced 22 Oct 2026
  • EUDAMED 05425023687505|542502368BDDMYOSITISTF 61 fields · synced 19 May 2026