Medical device licence · 105871 · Class 3
G-CEM ONE
Yes: licensed in Canada
Licence status Issued (active); first licensed February 22, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105871
- Licence holder
- GC America Inc.Alsip, Illinois, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 22, 2021
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- G-CEM ONE ADHESIVE ENHANCING PRIMER
- G-CEM ONE SELF-ADHESIVE RESIN CEMENT (SINGLE REFILL)
- G-CEM ONE SELF-ADHESIVE RESIN CEMENT (STARTER KIT)
- G-CEM ONE SELF-ADHESIVE RESIN CEMENT (SYSTEM KIT)
- G-CEM ONE SELF-ADHESIVE RESIN CEMENT (TWIN REFILL)
- G-CEM ONE UNIVERSAL SYSTEM KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.