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Blackford Accept Reject Tool

by Blackford Analysis Limited United Kingdom EUDAMED

Ref BART001

EMDN Z11069092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50605VIEWERSMK Basic UDI-DIDate28 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Blackford Accept Reject Tool
Model / Reference
BART001
Primary DI / UDI-DI
05060570830266
Basic UDI-DI
50605VIEWERSMK
Direct Marketing DI
05060570830266
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Norway

Manufacturer details

EUDAMED SRN
UK-MF-000044937
Authorised representative
Advena Limited MT-AR-000000234

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED b6667deb-a69e-47c7-92ae-1ad313095233 61 fields · synced 22 Oct 2026