Medical device licence · 21155 · Class 2
USA ELITE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 6, 2000. It is in Health Canada’s list of active licences.
- Licence number
- 21155
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 6, 2000
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- USA ELITE SYSTEM AND USA SERIES ELECTRODES
- USA ELITE SYSTEM CONTINUOUS FLOW RESECTOSCOPE
- USA ELITE SYSTEM ELEMENTS
- USA ELITE SYSTEM GYNECOLOGIC CONTINUOUS FLOW RESECTOSCOPE
- USA ELITE SYSTEM GYNECOLOGIC ROTATING CONTINUOUS FLOW RESECTOSCOPE
- USA ELITE SYSTEM RESECTOSCOPE
- USA ELITE SYSTEM ROTATING CONTINUOUS FLOW RESECTOSCOPE
- USA SERIES GYNECOLOGIC CONTINUOUS FLOW RESECTOSCOPE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.