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FocusedON-BC

by ARTIS Tech Development, S.L. Spain EUDAMED

Ref FOCUSEDON01Model v1.0.0

EMDN Z12040192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437029703FOCUSEDON01EK Basic UDI-DIDate22 Dec 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

Model / Reference
v1.0.0, FOCUSEDON01
Primary DI / UDI-DI
08437029703001
Basic UDI-DI
8437029703FOCUSEDON01EK
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000048734

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 6370c309-fc40-4efd-8b32-5cfc151f1241 61 fields · synced 22 Oct 2026