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ECG1M – Elettrocardiogramma in 1 minuto

by ECG1M SRL EUDAMED

Active European Union

Ref ECG1M

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805952920ECG1MAD Basic UDI-DIDate22 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 0425-MDR-030214-00 Issued

    Quality management system EU MDR

    Notified body
    ICIM S.P.A. 0425
    Issued
    6 Aug 2026
    Expires
    5 Aug 2031

Specification

EUDAMED

Model / Reference
ECG1M
Primary DI / UDI-DI
08059529200004
Basic UDI-DI
805952920ECG1MAD
EMDN Code
Z12050301 General purpose electrocardiographs
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000045066

Other devices from ECG1M SRL

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