ApprovalTrail

Medical device licence · 111840 · Class 3

F CARE RF SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed September 24, 2024. It is in Health Canada’s list of active licences.
Licence number
111840
Licence holder
F Care Systems NvBerchem, Belgium
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
September 24, 2024
Devices covered
5

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • HPR45I
  • MEDRF4000
  • RAFAELO
  • RAFAELO PROBE
  • SPHERA PROBE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.