Medical device licence · 94440 · Class 3
URETRON LITHOTRIPTER SYSTEM
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed January 5, 2015; ended November 30, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 94440
- Licence holder
- Ultrallege Usa Co. Ltd.Erie, PA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 5, 2015
- Ended
- November 30, 2020
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- URETRON FLEXIBLE PROBE
- URETRON GENERATOR
- URETRON HAND PIECE FOR FLEX/SEMI-FLEX PROBE
- URETRON HAND PIECE FOR RIGID PROBE
- URETRON LITHOTRIPTER SYSTEM
- URETRON RIGID PROBE
- URETRON SEMI-FLEXIBLE PROBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.