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Cortrium Apex

by Cortrium ApS Denmark EUDAMED

Ref Cortrium Apex

EMDN Z12050392

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5745000379ECG-SoftwareZ4 Basic UDI-DIDate21 Feb 2023RegisteredStatusActive

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
Cortrium Apex
Primary DI / UDI-DI
05745000379033
Basic UDI-DI
5745000379ECG-SoftwareZ4
EMDN Code
Z12050392 Electrocardiographs - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000007827

Other devices from Cortrium ApS

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 85ff6b84-ef03-4d66-ad76-6840ea5124d9 61 fields · synced 22 Oct 2026