Medical device licence · 96861 · Class 3
SIR-SPHERES
Yes: licensed in Canada
Licence status Issued (active); first licensed April 26, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96861
- Licence holder
- Sirtex Medical, Inc.Woburn, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 26, 2016
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIR-SPHERES DELIVERY SET
- SIR-SPHERES MICROSPHERES YTTRIUM-90
- SIR-SPHERES V-VIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.