Medical device licence · 105642 · Class 3
NGEN GENERATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed December 18, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105642
- Licence holder
- Biosense Webster, Inc.Irvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 18, 2020
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CABLE TX, NGEN CONSOLE TO CARTO SYSTEM
- CABLE, ECG STIMULATOR
- CABLE, NGEN CONSOLE TO NGEN PUMP
- CABLE, RS232 SERIAL COMMUNICATION
- DC CABLE, NGEN CONSOLE TO NGEN POWER SUPPLY UNIT
- ETHERNET CABLE
- ETHERNET CABLE, (FOR NGEN MONITOR OR FOR CARTO SYSTEM WORKSTATION)
- NGEN GENERATOR
- NGEN GENERATOR CABLE, CONSOLE TO EP RECORDING SYSTEM
- NGEN GENERATOR CONSOLE
- NGEN GENERATOR MONITOR
- NGEN GENERATOR POWER SUPPLY UNIT
- NGEN PEDAL
- POWER SUPPLY, NGEN MONITOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.