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Full Digital Colour Doppler Ultrasonic Diagnostic System

by Wuhan Zoncare Bio-medical Electronics Co., Ltd 2 variants

Ref /Model ZONCARE-N7

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 Number695691349506NF Basic UDI-DI 06956913495065UDI-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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Full Digital Colour Doppler Ultrasonic Diagnostic System
Model / Reference
ZONCARE-N7, /
Primary DI / UDI-DI
06956913495065
Basic UDI-DI
695691349506NF
EMDN Code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

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

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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