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Mobile C-arm X-ray System

by Beijing Wandong Medical Technology Co., Ltd. China EUDAMED

Ref N/AModel Hypernova-Y Plus, Flexion, Dyna-C300

EMDN Z11039017

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number693896431401NK Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Mobile C-arm X-ray System
Model / Reference
Hypernova-Y Plus, Flexion, Dyna-C300, N/A
Primary DI / UDI-DI
06938964324037
Basic UDI-DI
693896431401NK
EMDN Code
Z11039017 Mobile radioscopic units
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000014174
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Beijing Wandong Medical Technology Co., Ltd.

See all devices from Beijing Wandong Medical Technology Co., Ltd. →

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 7dd3751f-db31-446a-847a-c44d69c3dc86-1 61 fields · synced 22 Oct 2026