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Full Digital Colour Doppler Ultrasonic Diagnostic System

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

Ref /Model ZONCARE-M5

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K183041↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number695691349431N9 Basic UDI-DI 06956913494310UDI-DIDate24 Aug 2022RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK183041 Date10 Jul 2019IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Full Digital Colour Doppler Ultrasonic Diagnostic System
Model / Reference
ZONCARE-M5, /
Primary DI / UDI-DI
06956913494310
Basic UDI-DI
695691349431N9
EMDN Code
Z11040103 Portable ultrasound scanners
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