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Ec-12H

by LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság. Hungary EUDAMED

Ref SYS-12HLC-05Model EC-12H System

EMDN Z12050403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-SYS12HLC05QU Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
EC-12H 12-channel ECG Holter
Model / Reference
EC-12H System, SYS-12HLC-05
Primary DI / UDI-DI
D-SYS12HLC05QU
Basic UDI-DI
B-SYS12HLC05QU
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000002846

Other devices from LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.

See all devices from LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság. →

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 D-SYS12HLC05QU|B-SYS12HLC05QU 61 fields · synced 24 Oct 2026