Medical device licence · 106121 · Class 3
ENSITE X EP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 12, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106121
- Licence holder
- Abbott MedicalPlymouth, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 12, 2021
- Devices covered
- 24
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENSITE X AMPLIFIER AIR FILTER
- ENSITE X EP SYSTEM AMPERE CONNECT CABLE
- ENSITE X EP SYSTEM AMPLIFIER
- ENSITE X EP SYSTEM AMPLIFIER POWER MODULE
- ENSITE X EP SYSTEM CATHETER INPUT MODULE
- ENSITE X EP SYSTEM DISPLAY WORKSTATION
- ENSITE X EP SYSTEM ECG OUTPUT MODULE
- ENSITE X EP SYSTEM FIELD FRAME
- ENSITE X EP SYSTEM FIELD FRAME CABLE
- ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 1
- ENSITE X EP SYSTEM PATIENT REFERENCE SENSOR 3
- ENSITE X EP SYSTEM PFA GENERATOR CONNECT CABLE
- ENSITE X EP SYSTEM RADIO-LUCENT ECG CABLE
- ENSITE X EP SYSTEM RADIO-OPAQUE ECG CABLE
- ENSITE X EP SYSTEM RECORDING SYSTEM IC OUTPUT CABLE
- ENSITE X EP SYSTEM SOFTWARE UPGRADE
- ENSITE X EP SYSTEM SURFACELINK MODULE
- ENSITE X EP SYSTEM SYSTEM CABLE KIT
- ENSITE X EP SYSTEM SYSTEM CATHETER CONNECTOR CABLE
- ENSITE X EP SYSTEM SYSTEM UPGRADE KIT
- ENSITE X EP SYSTEM WORKMATE CLARIS CABLE IC56
- ENSITE X EP SYSTEM WORKMATE CLARIS CABLE IC64
- ENSITE X EP SYSTEM WORKMATE CLARIS ECG CABLE
- ENSITE X EP SYSTEM, TACTIFLEX ABLATION CATHETER, SENSOR ENABLED, SOFTWARE UPGRADE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.