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PMcardio® OMI AI ECG Model

by POWERFUL MEDICAL s.r.o.

Ref OMI AI ECG Model 1.0Model PMcardio® OMI AI ECG Model

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426073843PMcardio0002H4 Basic UDI-DI Date10 May 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
PMcardio® OMI AI ECG Model, OMI AI ECG Model 1.0
Primary DI / UDI-DI
04260738430173, 04260738430081
Basic UDI-DI
426073843PMcardio0002H4
Direct Marketing DI
04260738430173
04260738430081
EMDN Code
Z12050392 Electrocardiographs - medical device software
Device Class
Class IIb
Special Device Type
Software
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
SK-MF-000015799

Other devices from POWERFUL MEDICAL s.r.o.

Properties

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