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DIASpot Neptune ANA12 Screen IgG

by D-tek s.a. EUDAMED

Active European Union

Ref KAPDTANA12SNModel BlueDiver Dot

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number542502368BDDANAYE Basic UDI-DIDate23 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Device Name
BlueDiver Dot ANA Screening
Model / Reference
BlueDiver Dot, KAPDTANA12SN
Primary DI / UDI-DI
05425023688137
Basic UDI-DI
542502368BDDANAYE
Direct Marketing DI
05425023688137
EMDN Code
W0102100101 Ana screening
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

  • 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