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CardioMobile

by Oy Diagnostic Devices Development Finland EUDAMED

Ref 04Model CardioMobile-12

EMDN Z12050301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-FI-CA-01-2017-1780DZ Basic UDI-DIDate3 Dec 2021RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CardioMobile-12, 04
Primary DI / UDI-DI
D-FI-CA-01-2017-1780DZ
Basic UDI-DI
B-FI-CA-01-2017-1780DZ
EMDN Code
Z12050301 General purpose electrocardiographs
Device Class
Class IIa
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000017197

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (10)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f2274af3-a6a1-4b1e-ac60-2d6d0944457c 61 fields · synced 24 Oct 2026