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ECG cable and leadwire

by Dongguan Belcare Medical Technology Co., Ltd.

Ref ED-1340-AModel ED-1340-A/ED-1340-I/ED-1540-A/ED-1540-I/ED-1340R-A/ED-1340R-I/ED-1540R-A/ED-1540R-I/ELL-2340-A/ELL-2340-I/ELL-2540-A/ELL-2540-I/ECL-2320-A/ECL-2320-I/ECL-2520-A/ECL-2520-I/ECL-2321-A/ECL-2321-I/ECL-2521-A etc

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697657112KBECGCAL5C Basic UDI-DI 06976571123162UDI-DIDate28 May 2024RegisteredStatusActive

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  • Withdrawn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
ECG cable and leadwire
Model / Reference
ED-1340-A/ED-1340-I/ED-1540-A/ED-1540-I/ED-1340R-A/ED-1340R-I/ED-1540R-A/ED-1540R-I/ELL-2340-A/ELL-2340-I/ELL-2540-A/ELL-2540-I/ECL-2320-A/ECL-2320-I/ECL-2520-A/ECL-2520-I/ECL-2321-A/ECL-2321-I/ECL-2521-A etc, ED-1340-A
Primary DI / UDI-DI
06976571123162
Basic UDI-DI
697657112KBECGCAL5C
EMDN Code
Z12030680
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000035398
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Dongguan Belcare Medical Technology Co., Ltd.

See all devices from Dongguan Belcare 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