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Wellue

by Shenzhen Viatom Technology Co., Ltd. China EUDAMED

Ref Lepod ProModel M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12

EMDN Z12050402

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69344401M12WA Basic UDI-DIDate6 Jun 2023RegisteredStatusActive

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
Wireless Dynamic Multi-parameter Holter
Model / Reference
M5，M12，Lepod，Lepod Pro，LMT-5，LMT-12, Lepod Pro
Primary DI / UDI-DI
06934440102786
Basic UDI-DI
69344401M12WA
Direct Marketing DI
06934440102786
EMDN Code
Z12050402 Multi–parameter cardiovascular holter recorders (ECG, nipb, etc.)
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 bad50ed2-0e6d-441f-8d4d-f47b8e11ec16 61 fields · synced 24 Oct 2026