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Intco-Jyr

by Shanghai Intco Electrode Manufacturing Co., Ltd.

Ref SF70

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 Number697002005-0-ECG-9A Basic UDI-DI 06970020056056UDI-DIDate22 Apr 2026RegisteredStatusActive

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  • Withdrawn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 Electrodes
Model / Reference
SF70
Primary DI / UDI-DI
06970020056056
Basic UDI-DI
697002005-0-ECG-9A
EMDN Code
C020501 ECG electrodes
Device Class
Class I
EU market of registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000053403
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai Intco Electrode Manufacturing Co., Ltd.

See all devices from Shanghai Intco Electrode Manufacturing 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