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ECG Recorder

by Qingdao Weheal Technology co., Ltd China EUDAMED

Model E-10、E-20、E-30 EMDN Z12050403

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697638983E00UV Basic UDI-DIDate2 Mar 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
ECG Recorde
Model / Reference
E-10、E-20、E-30
Primary DI / UDI-DI
16976389830112
Basic UDI-DI
697638983E00UV
Direct Marketing DI
16976389830112
EMDN Code
Z12050403 ECG holter recorders
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000039585
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 4c2b2ac7-5ff6-4702-80cc-f0deedb7e208 61 fields · synced 23 Oct 2026