Skip to content

Lepu Medical

by Shenzhen Viatom Technology Co., Ltd. China EUDAMED

Ref LeHolter-3Model XAB-M3AG、 XAB-M12AL、 iHolter-3、 iHolter-12、 LeHolter-3、 LeHolter-12

EMDN Z12050403

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69344401iHolter-12LM Basic UDI-DIDate23 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Dynamic ECG Recorder
Model / Reference
XAB-M3AG、 XAB-M12AL、 iHolter-3、 iHolter-12、 LeHolter-3、 LeHolter-12, LeHolter-3
Primary DI / UDI-DI
06934440103349
Basic UDI-DI
69344401iHolter-12LM
Direct Marketing DI
06934440103349
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012182
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Viatom Technology Co., Ltd.

See all devices from Viatom Technology Co., Ltd. →

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 be14f436-6a20-4a7d-a70a-5a13e4cd88e8 61 fields · synced 24 Oct 2026