Medical device licence · 65882 · Class 3
FUJI II
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
- 65882
- 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
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FUJI II ASSORTED CAPSULE PACKAGE
- FUJI II CAPSULE PACKAGE
- FUJI II LIQUID
- FUJI II POWDER
- FUJI II STANDARD 1:1 PACKAGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.