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PMcardio

by POWERFUL MEDICAL s.r.o. Slovakia EUDAMED

Ref PMcardio 2.8 (iOS)Model PMcardio® EMDN Z12050392

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426073843PMcardio0001H2 Basic UDI-DIDate3 Jan 2023RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
PMcardio®
Model / Reference
PMcardio®, PMcardio 2.8 (iOS)
Primary DI / UDI-DI
04260738430098
Basic UDI-DI
426073843PMcardio0001H2
Direct Marketing DI
04260738430098
EMDN Code
Z12050392 Electrocardiographs - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Northern Ireland

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 480e0b05-3af9-4d68-9367-4840d7427d68 61 fields · synced 22 Oct 2026