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ECG Recorder

by Qingdao Weheal Technology co., Ltd China EUDAMED

Model Y-21,Y-22,Y-11,Y-12,Y-31,Y-32 EMDN Z12050403

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697638983Y00XZ Basic UDI-DIDate13 Aug 2024RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/MDR Withdrawn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 24 Oct 2026

Model / Reference
Y-21, Y-22, Y-11, Y-12, Y-31, Y-32
Primary DI / UDI-DI
26976389830096
Basic UDI-DI
697638983Y00XZ
Direct Marketing DI
26976389830096
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 93d1f293-734b-4caa-a01f-35a8302554eb 61 fields · synced 24 Oct 2026