Medical device licence · 98183 · Class 2
PLASMALOOP
Yes: licensed in Canada
Licence status Issued (active); first licensed December 6, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98183
- Licence holder
- Gunter Bissinger Medizintechnik GmbhTeningen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 6, 2016
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PLASMALOOP BIP. ELECTRODE BALL
- PLASMALOOP BIP. ELECTRODE KNIFE
- PLASMALOOP BIP. ELECTRODE LOOP
- PLASMALOOP CONTINUOUS FLOW INNER SHAFT
- PLASMALOOP CONTINUOUS FLOW OUTER SHAFT
- PLASMALOOP SINGLE SHAFT
- PLASMALOOP WORKING ELEMENT BIPOLAR ACTIVE
- PLASMALOOP WORKING ELEMENT BIPOLAR PASSIVE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.