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Telecardiocalm

by Cardio Calm S.R.L. EUDAMED

Active European Union

Ref CC0102Model 3

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B972TELECC32W Basic UDI-DIDate31 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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.

Specification

EUDAMED

Model / Reference
3, CC0102
Primary DI / UDI-DI
+B972CC01020B
Basic UDI-DI
++B972TELECC32W
EMDN Code
Z12050301,Z12050382,Z12050403,Z12050404,Z12050482
Device Class
Class IIa
Medical Purpose
TELECRADIOCALM is a remote telemedicine system that enables facilities distributed across the territory to perform diagnostic cardiological exams (ECG/Holter ECG/Blood Pressure Holter) and send them via the Internet for reporting by properly authorized cardiologists. The digitally signed report is then returned via the Internet.

Manufacturer details

EUDAMED SRN
IT-PR-000033759

Other devices from Cardio Calm S.R.L.

  • ECGCor

    Class IIa

  • BPCor

    Class IIa

  • ABPMWebCor

    Class I

  • RemoteCor

    Class I

  • Cer-S

    Class IIa

  • Cer-S

    Class IIa

Properties

Other properties (1)

  • Sterile: No