Medical device licence · 101713 · Class 3
REZUM SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 11, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101713
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 11, 2018
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REZUM
- REZUM DELIVERY DEVICE KIT FOR BPH MODEL D2201
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.