ApprovalTrail

Medical device licence · 65883 · Class 3

FUJI IX GP

Yes: licensed in Canada

Licence status Issued (active); first licensed September 22, 2004. It is in Health Canada’s list of active licences.
Licence number
65883
Licence holder
GC America Inc.Alsip, Illinois, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
September 22, 2004
Devices covered
7

Devices on this licence

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

  • FUJI IX GP CAPSULE PACKAGE
  • FUJI IX GP EXTRA CAPSULE PACKAGE
  • FUJI IX GP EXTRA SINGLE SHADE PACK
  • FUJI IX GP FAST CAPSULE PACKAGE
  • FUJI IX GP LIQUID
  • FUJI IX GP POWDER
  • FUJI IX GP STANDARD 1:1 PACKAGE

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