Medical device licence · 105727 · Class 3
MPS 3ND SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 19, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105727
- Licence holder
- Quest Medical, Inc.Allen, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 19, 2021
- Devices covered
- 29
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANTEGRADE/RETROGRADE Y-SET
- AORTIC ROOT TRANSDUCER INTERFACE CABLE (ANTEGRADE)
- CORONARY SINUS TRANSDUCER INTERFACE CABLE (RETROGRADE)
- DUAL LUMEN RETROGRADE EXTENSION LINE WITH Y-SET
- EXTENSION LINE
- MPS 3 ADDITIVE CARTRIDGE
- MPS 3 ARREST CARTRIDGE
- MPS 3 BLOOD BYPASS TUBING
- MPS 3 CABLE
- MPS 3 CONSOLE ADAPTER
- MPS 3 CONSOLE POLE MOUNT
- MPS 3 CONTROLLER
- MPS 3 ECG EXTENSION CABLE
- MPS 3 ECG SPLITTER
- MPS 3 MEDICAL AIR HOSE KIT
- MPS 3 MOUNTING ARM
- MPS 3 ND CONSOLE
- MPS 3 ND DELIVERY SETS
- MPS 3 ND HOSE CONNECTOR KIT
- MPS 3 POWER CORD
- MPS 3 TELESCOPING MOUNTING ARM
- MPS 3 UI POWER COMMUNICATION CABLE
- MPS ADDITIVE DELIVERY LINE
- MPS ARREST AGENT DELIVERY LINE
- MPS WATER CIRCUIT ADAPTER
- PRESSURE LINE WITH TRANSDUCER
- RETROGRADE EXTENSION PRESSURE LINE WITH TRANSDUCER
- RETROGRADE EXTENSION PRESSURE LINE WITH TRANSDUCER AND Y-SET
- TRANSDUCER HOLDER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.