Medical device licence · 111477 · Class 3
TRUPULSE GENERATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed July 5, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111477
- Licence holder
- Biosense Webster, Inc.Irvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 5, 2024
- Devices covered
- 24
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CABLE, CONSOLE TO NGEN PUMP 5M (16.4 FT)
- CABLE, ECG STIMULATOR, 2M (6.5 FT)
- ETHERNET CABLE WITH ISOLATOR & LOCKER
- ETHERNET CABLE, 10M (33FT)
- ETHERNET CABLE, 23M (75 FT)
- FIBER OPTIC CABLE FOR THE CONVERTER BOX, 25M
- FOOT SWITCH CABLE
- GENERATOR TO CARTO SYSTEM CABLE
- PEDAL, 4.9M (16FT)
- POWER SUPPLY CABLE FROM CONSOLE TO MONITOR
- REMOTE MONITOR HDMI FIBER OPTIC CABLE 10M
- REMOTE MONITOR HDMI FIBER OPTIC CABLE 30M
- REMOTE MONITOR HDMI FIBER OPTIC CABLE 50M
- REMOTE MONITOR USB FIBER OPTIC CABLE 10M
- REMOTE MONITOR USB FIBER OPTIC CABLE 30M
- REMOTE MONITOR USB FIBER OPTIC CABLE 50M
- TRUPULSE GENERATOR - CONSOLE
- TRUPULSE GENERATOR GENERATOR
- TRUPULSE GENERATOR MONITOR
- TRUPULSE GENERATOR REMOTE MONITOR
- TRUPULSE REMOTE MONITOR
- TRUPULSE VP PLUS SP KIT
- TRUPULSE VP PRO SW UPGRADE KIT
- USB COMMUNICATION CABLE FROM CONSOLE TO MONITOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.