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Myositis Profile 12 Ag OJ Dot for BDI

by D-tek s.a.

Ref AD MYOSO12ADBDModel 542502368BDDMYOSITISTF, BlueDiverDot Myositis

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05425023681770 Basic UDI-DI Date30 Aug 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
BlueDiver Dot Myositis
Model / Reference
542502368BDDMYOSITISTF, AD MYOSO12ADBD, BlueDiverDot Myositis
Primary DI / UDI-DI
05425023681770, 05425023687512
Basic UDI-DI
B-05425023681770, 542502368BDDMYOSITISTF
Direct Marketing DI
05425023687512
EMDN Code
W0102100108 Jo-1
Device Class
Class IVD General
Class B
EU 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