Skip to content

Digital Multi-Channel Electrocardiograph

by Wuhan Zoncare Bio-medical Electronics Co., Ltd

Ref /Model iMAC 1800，iMAC 1800pro

Active European Union

CE MDR CE MDD

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/MDD Number695691348217MW Basic UDI-DI 06956913482171UDI-DIDate24 Aug 2022RegisteredStatusActive
European UnionCE/MDR Number695691348217MW Basic UDI-DI 06956913482171UDI-DIDate24 Aug 2022RegisteredStatusActive

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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
Zoncare
Device Name
Digital Multi-Channel Electrocardiograph
Model / Reference
iMAC 1800，iMAC 1800pro, /
Primary DI / UDI-DI
06956913482171
Basic UDI-DI
695691348217MW, B-06956913482171
EMDN Code
Z12050302, Z12050301
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000010439
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Wuhan Zoncare Bio-medical Electronics Co., Ltd

  • Zoncare

    Class IIa

  • Zoncare

    Class IIa

  • Zoncare

    Class IIa

  • Zoncare

    Class IIa

  • Zoncare

    Class IIa

  • Zoncare

    Class IIa

See all devices from Wuhan Zoncare Bio-medical Electronics Co., Ltd →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No