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Falck AcuCare

by Medixine Oy Finland EUDAMED

Ref Falck AcuCareModel Medixine Suite

EMDN Z12040192

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number64298300897MXSuiteT8 Basic UDI-DIDate18 Aug 2022RegisteredStatusActive

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
Medixine Suite
Model / Reference
Medixine Suite, Falck AcuCare
Primary DI / UDI-DI
06429830089728
Basic UDI-DI
64298300897MXSuiteT8
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
FI-MF-000002552

Other devices from Medixine Oy

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 5055abb9-10b7-435b-b9ed-fa6f5b50f70b 61 fields · synced 22 Oct 2026