Medical device licence · 62646 · Class 3
GRADIA DIRECT
Yes: licensed in Canada
Licence status Issued (active); first licensed June 6, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 62646
- Licence holder
- GC America Inc.Alsip, Illinois, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 6, 2003
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GRADIA DIRECT SYRINGE, ANTERIOR
- GRADIA DIRECT SYRINGE, POSTERIOR
- GRADIA DIRECT UNITIP, ANTERIOR
- GRADIA DIRECT UNITIP, POSTERIOR
- GRADIA DIRECT X SYRINGE
- GRADIA DIRECT X UNITIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.