Medical device licence · 80473 · Class 3
GC KALORE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 14, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80473
- Licence holder
- GC America Inc.Alsip, Illinois, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group
- First licensed
- August 14, 2009
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GC KALORE 10 UNITIP, SHADE
- GC KALORE 20 UNITIP, SHADE
- GC KALORE SYRINGE, SHADE
- GC KALORE TRIAL KIT SYRINGE
- GC KALORE TRIAL KIT UNITIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.