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X-ray equipment for computed tomography

by SinoVision Healthcare (Yangzhou) Co., Ltd. China EUDAMED

Ref AlphaCT 328 Plus, AlphaCT 358 Plus EMDN Z11030603

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697449021SNVSYZ3281CB Basic UDI-DIDate10 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
X-ray equipment for computed tomography
Model / Reference
AlphaCT 328 Plus, AlphaCT 358 Plus
Primary DI / UDI-DI
16974490210014, 16974490210038
Basic UDI-DI
697449021SNVSYZ3281CB, 697449021SNVSYZ3581CS
Direct Marketing DI
16974490210014
16974490210038
EMDN Code
Z11030603 Computed tomographs - 16 layers or more but less than 64 layers
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011927
Authorised representative
MedPath GmbH DE-AR-000000087

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED 99a75906-39cd-4926-83e6-84d346e371af 61 fields · synced 22 Oct 2026
  • EUDAMED 16974490210038|697449021SNVSYZ3581CS 61 fields · synced 17 May 2026