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ECG Recorder

by Qingdao Weheal Technology co., Ltd China EUDAMED

Ref NoneModel Y-21,Y-22,Y-11,Y-12,Y-31,Y-32

EMDN Z12050403

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697638983Y00XZ Basic UDI-DIDate13 Aug 2024RegisteredStatusActive

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
ECG Recorder
Model / Reference
Y-21, Y-22, Y-11, Y-12, Y-31, Y-32, None
Primary DI / UDI-DI
06976389830061
Basic UDI-DI
697638983Y00XZ
Direct Marketing DI
06976389830061
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

Other devices from Qingdao Weheal Technology co., Ltd

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 0142e755-e9d4-4899-87a0-a43cad97b86e 61 fields · synced 22 Oct 2026