ApprovalTrail

Medical device licence · 79923 · Class 3

OPERA FP

Yes: licensed in Canada

Licence status Issued (active); first licensed June 9, 2009. It is in Health Canada’s list of active licences.
Licence number
79923
Licence holder
General Medical Merate S.P.A.Seriate, BG, Italy
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 9, 2009
Devices covered
4

Devices on this licence

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

  • OPERA FP - OPERA D400RF IMAGING SYSTEM WITH R&F DIGITAL DETECTOR
  • OPERA FP - OPERA G GENERATOR AND CONTROLS
  • OPERA FP - OPERA T90FPE POSITIONER AND CONTROLS
  • OPERA FP - X-RAY REMOTE R&F SYSTEM - MAIN UNIT

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