Medical device licence · 104858 · Class 2
OPTILUME BPH CATHETER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 2, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104858
- Licence holder
- Urotronic, Inc.Minneapolis, MN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 2, 2020
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTILUME BPH PROSTATIC DILATION DCB CATHETER 90 FR
- OPTILUME BPH PROSTATIC PRE-DILATION CATHETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.