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Hedy Telemonitoring System

by Health Care Systems GmbH Germany EUDAMED

Ref 3, 5

EMDN Z12050801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426065832HedyTMW4 Basic UDI-DIDate21 Feb 2022RegisteredStatusActive

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
3, 5
Primary DI / UDI-DI
04260658320042, 04260658320080
Basic UDI-DI
426065832HedyTMW4
EMDN Code
Z12050801 Complete cardiac telemetry systems
Device Class
Class IIa
Medical Purpose
„Hedy Telemonitoring System“ ist bestimmt für die Durchführung von Telemonitoring von Patienten mit Herzinsuffizienz in häuslicher Umgebung.

Manufacturer details

EUDAMED SRN
DE-PR-000020378

Other devices from Health Care Systems GmbH

Properties & raw data

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

Sources (2)

  • EUDAMED 1c0d8549-b685-493f-96e2-193119669ecf 61 fields · synced 22 Oct 2026
  • EUDAMED 531ed9cb-8031-4004-bffa-f100013c88a3 61 fields · synced 19 May 2026