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Digital Ultrasonic Diagnostic Imaging System

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 7 variants

Ref DP-70 Expert, DP-20T, DP-10T, DP-50, DP-30T, DP-18, DP-10Model DP-50/DP-50T/DP-50 PT/DP-50Pro/DP-50Expert/DP-50S/DP-50W/DP-70/DP-70T/DP-70 Pro/DP-70 Expert/DP-70C, DP-10, DP-10T, DP-11, DP-15, DP-18, DP-20, DP-20T, DP-21, DP-25, DP-28, DP-30, DP-30T, DP-36

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111435↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69449040AB050100145Q Basic UDI-DI Date23 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06936415973414 UDI-DI Date28 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK111435 Date8 Jul 2011IssuedStatusActive

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

1 recall · FDA

    • Terminated Z-1330-2020 FDA Class II initiated 13 Jan 2020

    The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.

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  • Withdrawn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) · GUDID

Trade Name
DP-10 Diagnostic Ultrasound System
DP-50 Ultrasound system
Generic Name
General-purpose ultrasound imaging system
Device Name
Digital Ultrasonic Diagnostic Imaging System
Model / Reference
DP-50/DP-50T/DP-50 PT/DP-50Pro/DP-50Expert/DP-50S/DP-50W/DP-70/DP-70T/DP-70 Pro/DP-70 Expert/DP-70C, DP-70 Expert, DP-10, DP-10T, DP-11, DP-15, DP-18, DP-20, DP-20T, DP-21, DP-25, DP-28, DP-30, DP-30T, DP-36, DP-50
Primary DI / UDI-DI
06936415973414, 06936415978044, 06936415977993, 06944904030500, 06936415978099, 06936415978037, 06944904030531
Basic UDI-DI
69449040AB050100145Q, 69449040AB050100135N
510(k) Number
FDA Product Code
IYN, IYO
EMDN Code
Z11040103 Portable ultrasound scanners
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1550, 892.1560
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No