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ECG Event Recorder

by BORSAM Biomedical Instruments Co., Ltd. China EUDAMED

Ref WeCardio UN, WeCardio WF EMDN Z12050403

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06934666200013 Basic UDI-DIDate24 Oct 2025RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
WeCardio UN, WeCardio WF
Primary DI / UDI-DI
06934666200013, 06934666200167
Basic UDI-DI
B-06934666200013, B-06934666200167
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000023994
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from BORSAM Biomedical Instruments Co., Ltd.

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 (2)

  • EUDAMED ca42f5c0-a662-4cba-93c2-69678077b19b 61 fields · synced 22 Oct 2026
  • EUDAMED 06934666200167|B-06934666200167 61 fields · synced 19 May 2026