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MAIPA Assay

by Advanced Practical Diagnostics Belgium EUDAMED

Ref 900016 Model 900006 and 900016

EMDN W010399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5430000412900006Q2 Basic UDI-DIDate20 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
900006 and 900016, 900016
Primary DI / UDI-DI
05430000412124
Basic UDI-DI
5430000412900006Q2
EMDN Code
W010399 Haematology / haemostasis / immunohaematology / histology / cytology reagents - other
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
BE-MF-000000572

Other devices from Advanced Practical Diagnostics

See all devices from Advanced Practical Diagnostics →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 212a708e-9eb8-47f4-8e57-62b9834068c4 61 fields · synced 22 Oct 2026