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Sb-301DC

by Shanghai Kohden Medical Electronic Instrument Corp. China EUDAMED

Ref NAModel SB-301DC

EMDN Z12050380

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697001088SB-301DC82 Basic UDI-DIDate27 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
SB-301DC, NA
Primary DI / UDI-DI
06970010881613
Basic UDI-DI
697001088SB-301DC82
EMDN Code
Z12050380 Electrocardiographs - hardware accessories
Device Class
Class I
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 97d6c319-c016-4a31-a70e-c0a6875665c4 61 fields · synced 22 Oct 2026