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Ec-12R

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

Ref SYS-0012R-05Model EC-12R

EMDN Z12050301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05999883490204 Basic UDI-DIDate26 Feb 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 25 Oct 2026

Device Name
EC-12R PC-based 12-channel Resting ECG
Model / Reference
EC-12R, SYS-0012R-05
Primary DI / UDI-DI
05999883490204
Basic UDI-DI
B-05999883490204
EMDN Code
Z12050301 General purpose electrocardiographs
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 05999883490204|B-05999883490204 61 fields · synced 25 Oct 2026