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Opescope Acteno FD15

by GENORAY CO., Ltd. South Korea EUDAMED

Ref A02 EMDN Z11039009

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880924406OSCAR15UD Basic UDI-DIDate13 Apr 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Device Name
OSCAR 15FD (Unique FD, OPESCOPE ACTENO FD15, SC15), OSCAR 15i, OSCAR 15iL
Model / Reference
A02
Primary DI / UDI-DI
08809244060687
Basic UDI-DI
880924406OSCAR15UD
EMDN Code
Z11039009 Fluoroscopy devices
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000021014
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Genoray Co., Ltd.

See all devices from Genoray 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 a54c1cbf-fb95-4251-a0dd-6dd0f8a54516 61 fields · synced 25 Oct 2026