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Diagnostic Ultrasound System

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 234 variants

Ref DC-35Model DC-33, DC-35, DC-36, DC-38, DC-39, DC-33S, DC-35S, DC-36S, DC-38S, DC-39S, DC-35 Pro, DC-35 Exp, DC-N3 Exp, DC-N3 Elite, DC-Eva, DC-40, DC-41, DC-42, DC-43, DC-44, DC-45, DC-40S, DC-40 Pro, DC-40 Exp, DC-40T

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06944904092034 UDI-DI Date17 Feb 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69449040AB050100105G Basic UDI-DI 06944904092034UDI-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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
DC-35 Diagnostic Ultrasound System
Generic Name
General-purpose ultrasound imaging system
Device Name
Diagnostic Ultrasound System
Model / Reference
DC-33, DC-35, DC-36, DC-38, DC-39, DC-33S, DC-35S, DC-36S, DC-38S, DC-39S, DC-35 Pro, DC-35 Exp, DC-N3 Exp, DC-N3 Elite, DC-Eva, DC-40, DC-41, DC-42, DC-43, DC-44, DC-45, DC-40S, DC-40 Pro, DC-40 Exp, DC-40T
Primary DI / UDI-DI
06944904092034
Basic UDI-DI
69449040AB050100105G
510(k) Number
FDA Product Code
IYN
EMDN Code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1550
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

  • Serial Number
  • Manufacturing Date

Other properties (22)

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