Medical device licence · 11557 · Class 3
ELECTROSURGICAL POWER UNITS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 8, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11557
- Licence holder
- Conmed CorporationUtica, NY, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- September 8, 1999
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BICAP III ELECTROSURGICAL GENERATOR
- BISTAT BIPOLAR GENERATOR (ELECTROSURGICAL UNIT)
- EXCALIBUR PLUS PC ES UNIT
- HYFRECATOR 2000
- SABRE 180 ELECTROSURGICAL UNIT
- SABRE 2400 ELECTROSURGICAL UNIT
- SABRE GENESIS
- SYSTEM 2450 ESU
- SYSTEM 2500
- SYSTEM 5000
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.