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BluePrint FFPE microarray

by Agendia N.V Netherlands EUDAMED

Ref NA (Centralized Lab Product)

EMDN W05039099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0850024841BlueprintBB Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
BluePrint Diagnostic Microarray
Model / Reference
NA (Centralized Lab Product)
Primary DI / UDI-DI
00850024841338
Basic UDI-DI
0850024841BlueprintBB
EMDN Code
W05039099 Devices for samples analyses - other
Device Class
Class C
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000011684

Other devices from Agendia N.V

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED ad747884-426f-4e00-9e28-48b9a3204dd5 61 fields · synced 24 Oct 2026