Medical device licence · 61148 · Class 3
COMBI 500
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed December 5, 2002; ended March 3, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61148
- Licence holder
- Gymnauniphy N.V.Bilzen, Belgium
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 5, 2002
- Ended
- March 3, 2004
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMBI 500
- COMBI 500 - LASER TREATMENT HEAD
- COMBI 500 - REMOTE INTERLOCK FOR LASER
- COMBI 500 - TREATMENT GUIDE
- COMBI 500 - ULTRASOUND TREATMENT HEAD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.