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VIREOFLEX3

by livetec Ingenieurbüro GmbH Germany EUDAMED

Ref 107158

EMDN Z12050403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426058522ECG-RecorderB8 Basic UDI-DIDate9 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
ECG Holter Recorder
Model / Reference
107158
Primary DI / UDI-DI
04260585221818
Basic UDI-DI
426058522ECG-RecorderB8
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005598

Other devices from livetec Ingenieurbüro GmbH

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Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 05144c32-2890-4051-9026-0055c61eec94 61 fields · synced 23 Oct 2026