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EKG Cable and Leadwires

by Shenzhen Best Electronics Co., Ltd 10 variants

Ref BKY12-IGModel BKYXX-XX;BKFX-XXX;BKD-XX

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697123682BKYXX-XXXX28 Basic UDI-DI 06971236828529UDI-DIDate12 Mar 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
EKG Cable and Leadwires
Model / Reference
BKYXX-XX, BKFX-XXX, BKD-XX, BKY12-IG
Primary DI / UDI-DI
06971236828529
Basic UDI-DI
697123682BKYXX-XXXX28
Direct Marketing DI
06971236828529
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000037463
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Best Electronics Co., Ltd

See all devices from Shenzhen Best Electronics Co., Ltd →

Properties

  • Reusable
  • Measuring Function

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No