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X33 Elite

by Sonoscape Medical Corp. China EUDAMED

Ref _Model X11 Exp

EMDN Z11040103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69458686U1024SM Basic UDI-DIDate13 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Digital Color Doppler ultrasound System
Model / Reference
X11 Exp, _
Primary DI / UDI-DI
06945868615994
Basic UDI-DI
69458686U1024SM
EMDN Code
Z11040103 Portable ultrasound scanners
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000009623
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Sonoscape Medical Corp.

See all devices from Sonoscape Medical Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06945868615994|69458686U1024SM 61 fields · synced 24 Oct 2026