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Digital Ultrasonic Diagnostic Imaging System

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 2 variants

Ref DP-25Model 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-36510(k) K113632

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) K113632↗

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 Number69449040AB050100135N Basic UDI-DI 06936415978075UDI-DIDate23 Oct 2023RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK113632 Date25 Jan 2012ClearedStatusActive

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  • Withdrawn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
Digital Ultrasonic Diagnostic Imaging System
Model / Reference
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
Primary DI / UDI-DI
06936415978075
Basic UDI-DI
69449040AB050100135N
510(k) Number
FDA Product Code
IYO
EMDN Code
Z11040103 Portable ultrasound scanners
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.1560
EU market of registration
Germany
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
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.

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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