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Diagnostic Ultrasound System

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

Ref Crius M11Model M9/M9T/M9CV/M9GI/M8/M8CV/M8T/M8GI/M10/M10CV/M10S/M10T/M10 Exp/M10 Pro/Anesus M10/Crius M10/ Emerus M10/MVP /M11/M11CV/M11S/M11T/M11 Exp/M11 Pro/Anesus M11/Crius M11/Operus M11/Monet/M9 Premium

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06903053016483 UDI-DI Date9 Jan 2026ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number69449040AB050100045M Basic UDI-DI 06903053016483UDI-DIDate18 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 22 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  • Withdrawn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

Generic Name
General-purpose ultrasound imaging system
Model / Reference
M9/M9T/M9CV/M9GI/M8/M8CV/M8T/M8GI/M10/M10CV/M10S/M10T/M10 Exp/M10 Pro/Anesus M10/Crius M10/ Emerus M10/MVP /M11/M11CV/M11S/M11T/M11 Exp/M11 Pro/Anesus M11/Crius M11/Operus M11/Monet/M9 Premium, Crius M11
Primary DI / UDI-DI
06903053016483
Basic UDI-DI
69449040AB050100045M
510(k) Number
FDA Product Code
IYN
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
EU market of registration
Germany
GUDID distribution status
Not 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