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SZcaremed

by Shenzhen Caremed Medical Technology Co., Ltd. 188 variants

Ref EDU367－AModel EK10U-NK2-BI

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69707585ECG01QK Basic UDI-DI 06931973456386UDI-DIDate14 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
EKG Cable
Model / Reference
EK10U-NK2-BI, EDU367－A
Primary DI / UDI-DI
06931973456386
Basic UDI-DI
69707585ECG01QK
Direct Marketing DI
06931973456386
EMDN Code
C020599 Cardiac diagnostic devices - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000010579
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Caremed Medical Technology Co., Ltd.

See all devices from Shenzhen Caremed Medical Technology Co., Ltd. →

Properties

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