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Digital Ultrasonic Diagnostic Imaging System

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

Ref DP-50SModel 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

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06936415981150 UDI-DI Date22 Jan 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69449040AB050100145Q Basic UDI-DI 06936415981150UDI-DIDate23 Oct 2023RegisteredStatusActive

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
DP-50S Digital Ultrasonic Diagnostic Imaging 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-50S
Primary DI / UDI-DI
06936415981150
Basic UDI-DI
69449040AB050100145Q
FDA Product Code
IYO
EMDN Code
Z11040103 Portable ultrasound scanners
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560
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