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PMcardio® Core AI ECG Model

by POWERFUL MEDICAL s.r.o. Slovakia EUDAMED

Ref Core AI ECG ModelModel PMcardio® Core AI ECG Model EMDN Z12050392

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426073843PMcardio0003H6 Basic UDI-DIDate8 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
PMcardio® Core AI ECG Model, Core AI ECG Model
Primary DI / UDI-DI
04260738430135
Basic UDI-DI
426073843PMcardio0003H6
Direct Marketing DI
04260738430135
EMDN Code
Z12050392 Electrocardiographs - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
SK-MF-000015799

Other devices from POWERFUL MEDICAL s.r.o.

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 302d0ef2-6659-4f9b-8046-7d0bfefe06e0 61 fields · synced 24 Oct 2026