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Qs-315E

by Shanghai Kohden Medical Electronic Instrument Corp. China EUDAMED

Model QS-315E EMDN Z12050382

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697001088QS-315E9T Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
QS-315E
Primary DI / UDI-DI
06970010881644
Basic UDI-DI
697001088QS-315E9T
EMDN Code
Z12050382 Electrocardiographs - software 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 06970010881644|697001088QS-315E9T 61 fields · synced 25 Oct 2026