ApprovalTrail

Medical device licence · 65880 · Class 3

FUJI II LC

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
65880
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
6

Devices on this licence

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

  • FUJI II LC 3:1:1 PACKAGE
  • FUJI II LC CAPSULE PACKAGE
  • FUJI II LC CORE MATERIAL
  • FUJI II LC LIQUID
  • FUJI II LC POWDER
  • FUJI II LC STANDARD 1:1 PACKAGE

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