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wellue

by Shenzhen Viatom Technology Co., Ltd. China EUDAMED

Ref EPatch-DModel ER1-LW，ER1-LB

EMDN Z12050403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69344401ER1-LWER 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 22 Oct 2026

Device Name
Dynamic ECG Recorder
Model / Reference
ER1-LW，ER1-LB, EPatch-D
Primary DI / UDI-DI
06934440103707
Basic UDI-DI
69344401ER1-LWER
Direct Marketing DI
06934440103707
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 c4c41c07-4abf-4200-ae93-cc0a7c5edcd3 61 fields · synced 22 Oct 2026