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Diagnostic Ultrasound System

by Canon Inc. 2 variants

Ref CUS-AME00Model CUS-ABE00, CUS-AME00, TUS-AI900, etc.

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4987670A0401RF Basic UDI-DI 04987670106569UDI-DIDate28 Aug 2026RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Diagnostic Ultrasound System
Model / Reference
CUS-ABE00, CUS-AME00, TUS-AI900, etc.
Primary DI / UDI-DI
04987670106569
Basic UDI-DI
4987670A0401RF
EMDN Code
Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000013254
Authorised representative
Canon Medical Systems Europe B.V. NL-AR-000010531

Other devices from Canon Inc.

See all devices from Canon Inc. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No