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Disposable ECG electrode

by Shanghai Zhichen Medical Technology Co., Ltd

Ref CM01Model CM01,CM02,CM03,CM04,CM05,CM06,CM07,CM08,CM09,CM10,CM11,CM12,CM13,CM14,CM15,CM16,CM17,CM18,CM19,CM20,CM21,CM22,CM23,CM24,CM25,CM26,CM27,CM28,CM29,CM30,CM31,CM32,CM33,CM34,CM35,CM36,CM37,CM38 CK01,CK02,CK03,CK04,CK05,CK06,CK07,CK08,CK09,CK10,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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697687986DEE01UK Basic UDI-DI 06976879860011UDI-DIDate20 Nov 2023RegisteredStatusActive

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  • Withdrawn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
Disposable ECG electrode
Model / Reference
CM01, CM02, CM03, CM04, CM05, CM06, CM07, CM08, CM09, CM10, CM11, CM12, CM13, CM14, CM15, CM16, CM17, CM18, CM19, CM20, CM21, CM22, CM23, CM24, CM25, CM26, CM27, CM28, CM29, CM30, CM31, CM32, CM33, CM34, CM35, CM36, CM37, CM38 CK01, CK02, CK03, CK04, CK05, CK06, CK07, CK08, CK09, CK10, etc
Primary DI / UDI-DI
06976879860011
Basic UDI-DI
697687986DEE01UK
EMDN Code
K0201010301, K0201010302
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038646
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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