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EC Sense System

by Cardiolex Medical AB Sweden EUDAMED

Ref CN S

EMDN Z12050301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7350117580000000001YH Basic UDI-DIDate29 Jan 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CN S
Primary DI / UDI-DI
07350117580012
Basic UDI-DI
7350117580000000001YH
EMDN Code
Z12050301 General purpose electrocardiographs
Device Class
Class IIa
Medical Purpose
The system is intended for use by health care professionals to acquire, present and analyze ECG data with the purpose of providing input to diagnostic decisions.

Manufacturer details

EUDAMED SRN
SE-PR-000016896

Other devices from Cardiolex Medical AB

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (1)

  • EUDAMED 95f25328-31f9-427e-8bb8-fbaf5f48e0c1 61 fields · synced 22 Oct 2026