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Yd-321D

by Shanghai Kohden Medical Electronic Instrument Corp. China EUDAMED

Ref NAModel YD-321D

EMDN Z12050380

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697001088YD-321D7P Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
YD-321D, NA
Primary DI / UDI-DI
06970010881699
Basic UDI-DI
697001088YD-321D7P
EMDN Code
Z12050380 Electrocardiographs - hardware accessories
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000013567
Authorised representative
NIHON KOHDEN EUROPE GmbH DE-AR-000010740

Other devices from Shanghai Kohden Medical Electronic Instrument Corp.

See all devices from Shanghai Kohden Medical Electronic Instrument Corp. →

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 7aa2be20-bd3e-4f0a-8afe-3fc2e72e0352 61 fields · synced 22 Oct 2026