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Diagnostic Ultrasound System

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 281 variants

Ref Z50 ExpertModel Z5, Z5T, Z5BW, Z50, Z50T, Z50BW, Z50S, Z50W, Z50 Pro, Z50 Expert, Z70, Z70S, Z70 Pro, Z70 Expert

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200251↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69449040AB050100165U Basic UDI-DI 06936415973292UDI-DIDate13 Oct 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK200251 Date2 Apr 2020IssuedStatusActive

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 25 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  • Withdrawn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
Diagnostic Ultrasound System
Model / Reference
Z5, Z5T, Z5BW, Z50, Z50T, Z50BW, Z50S, Z50W, Z50 Pro, Z50 Expert, Z70, Z70S, Z70 Pro, Z70 Expert
Primary DI / UDI-DI
06936415973292
Basic UDI-DI
69449040AB050100165U
EMDN Code
Z11040103 Portable ultrasound scanners
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

See all devices from Shenzhen Mindray Bio-Medical Electronics 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