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EC-12H/ABP V6 System

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

Ref EC-12H/ABP V6 SystemModel EC type Holter systems EMDN Z12050402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5999883490HOLTERSR9 Basic UDI-DIDate10 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
EC type Holter systems, EC-12H/ABP V6 System
Primary DI / UDI-DI
05999883490570
Basic UDI-DI
5999883490HOLTERSR9
Direct Marketing DI
05999883490570
EMDN Code
Z12050402 Multi–parameter cardiovascular holter recorders (ECG, nipb, etc.)
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 (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 05999883490570|5999883490HOLTERSR9 61 fields · synced 25 Oct 2026