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Ec-3H/Abp

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

Ref SET-3H/ABP-05 BModel EC-3H/ABP Recorder EMDN Z12050402

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05999883490037 Basic UDI-DIDate4 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
EC-3H/ABP 3-channel ECG Holter and Ambulatory Blood Pressure Monitor
Model / Reference
EC-3H/ABP Recorder, SET-3H/ABP-05 B
Primary DI / UDI-DI
05999883490037
Basic UDI-DI
B-05999883490037
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 (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 8a4f07ff-79e1-42aa-baf1-0247453605d3 61 fields · synced 24 Oct 2026