Medical device licence · 105077 · Class 3
VIO 3 ELECTROSURGICAL UNIT
Yes: licensed in Canada
Licence status Issued (active); first licensed August 27, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105077
- Licence holder
- Erbe Elektromedizin GmbhTuebingen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 27, 2020
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BICLAMP KNIFE
- BIPOLAR CABLE
- BIPOLAR CONNECTING CABLE
- CABLE FOR RETURN ELECTRODE/USA
- HYBRIDKNIFE FLEX I-TYPE
- HYBRIDKNIFE FLEX T-TYPE
- MONOPOLAR CABLE / USA BOVIEJACK OD 8
- MONOPOLAR CABLE MO 3 PIN
- ONE-PEDAL FOOT SWITCH VIO 3 REMODE
- TWO-PEDAL FOOT SWITCH; VIO 3 REMODE
- TWO-PEDAL FOOT SWITCH; VIO 3 REMODE; BRACKET
- TWO-PEDAL FOOT SWITCH; VIO 3 REMODE; BRACKET; MIDDLE PIECE
- TWO-PEDAL FOOT SWITCH; VIO 3 REMODE; MIDDLE PIECE
- VIO 3 ELECTROSURGICAL UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.