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Rafaelo

by F Care Systems Belgium EUDAMED

Ref 00RAFAELOModel Rafaelo

EMDN Z12010905

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-05425025630196 Basic UDI-DIDate11 Apr 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 22 Oct 2026

Model / Reference
Rafaelo, 00RAFAELO
Primary DI / UDI-DI
05425025630196
Basic UDI-DI
B-05425025630196
EMDN Code
Z12010905 Radiosurgical units
Device Class
Class IIb
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000037

Other devices from F Care Systems

See all devices from F Care Systems →

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 2b62b663-486f-46b8-8f48-272a4f406172 61 fields · synced 22 Oct 2026