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Zoncare

by Wuhan Zoncare Bio-medical Electronics Co., Ltd 32 variants

Ref /Model iMAC 12,iMAC 12pro,iMAC 120,iMAC 120pro,iMAC 300,iMAC 300pro，E120,E120s,E120pro,E12,E12s,E12pro,E30,E30s,E30pro

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 linked in EUDAMED

A group certificate may exist

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 Number695691348214MQ Basic UDI-DI 06956913490046UDI-DIDate1 Jul 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Digital Multi-channel Electrocardiograph
Model / Reference
iMAC 12, iMAC 12pro, iMAC 120, iMAC 120pro, iMAC 300, iMAC 300pro，E120, E120s, E120pro, E12, E12s, E12pro, E30, E30s, E30pro, /
Primary DI / UDI-DI
06956913490046
Basic UDI-DI
695691348214MQ
EMDN Code
Z12050301 General purpose electrocardiographs
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000010439
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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

Properties

  • Implantable

Other properties (12)

  • Sterile: 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