Medical device licence · 96518 · Class 3
G-AENIAL COMPOSITES
Yes: licensed in Canada
Licence status Issued (active); first licensed February 11, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96518
- Licence holder
- GC America Inc.Alsip, Illinois, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- February 11, 2016
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- G-AENIAL A'CHORD SAMPLES
- G-AENIAL A'CHORD SYRINGE
- G-AENIAL A'CHORD SYRINGE TRIAL KITS
- G-AENIAL A'CHORD UNITIP
- G-AENIAL A'CHORD UNITIP TRIAL KITS
- G-AENIAL SCULPT SYRINGE
- G-AENIAL SCULPT UNITIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.