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Mobile C-Arm X-ray system

by DK Medical Systems Co., Ltd. United States EUDAMED

Ref PROSTAR

EMDN Z11039009

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800001611302 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Mobile C-Arm X-ray system
Model / Reference
PROSTAR
Primary DI / UDI-DI
08800001611302
Basic UDI-DI
B-08800001611302
EMDN Code
Z11039009 Fluoroscopy devices
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
KR-MF-000006102
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Dk Medical Systems Co., Ltd.

See all devices from Dk Medical Systems Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8ee34982-0c33-4348-8602-ca8bc4087a97 61 fields · synced 24 Oct 2026