Medical device licence · 17946 · Class 2
CYSTOURETHROSCOPES
Yes: licensed in Canada
Licence status Issued (active); first licensed March 2, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 17946
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 2, 2000
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLASSIC SERIES PEDIATRIC CYSTOSCOPES
- USA ELITE SYSTEM CONTINUOUS FLOW LASER CYSTOURETHROSCOPE
- USA ELITE SYSTEM CYSTOURETHROSCOPE
- USA SERIES CYSTOURETHROSCOPE
- USA SERIES CYSTOURETHROSCOPE, CONTINUOUS FLOW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.