Medical device licence · 103887 · Class 3
TULSA-PRO SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 20, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103887
- Licence holder
- Profound Medical Inc.Mississauga, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 20, 2019
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TULSA-PRO DISPOSABLE KIT
- TULSA-PRO ENDORECTAL COOLING DEVICE
- TULSA-PRO FILTER BOX
- TULSA-PRO MANGANESE CHLORIDE - ECD FLUID SUPPLEMENT
- TULSA-PRO POSITIONING SYSTEM
- TULSA-PRO POSITIONING SYSTEM INTERFACE BOX
- TULSA-PRO SPAN & TWEEN - ECD FLUID SUPPLEMENT
- TULSA-PRO SYSTEM
- TULSA-PRO SYSTEM CART
- TULSA-PRO SYSTEM ELECTRONICS
- TULSA-PRO TREATMENT DELIVERY CONSOLE
- TULSA-PRO TUBE SET ENDORECTAL COOLING DEVICE
- TULSA-PRO TUBE SET ULTRASOUND APPLICATOR
- TULSA-PRO ULTRASOUND APPLICATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.