Medical device licence · 99009 · Class 3
QUANTUM PERFUSION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 21, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99009
- Licence holder
- Spectrum Medical SrlGloucester, United Kingdom
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 21, 2017
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANAESTHETIC GAS SENSOR ASSY
- BLOOD PRESSURE SENSOR
- EM-TEC FLOW SENSOR
- HB-SO2 SENSOR
- QUANTUM CENTRIFUGAL DRIVE
- QUANTUM CENTRIFUGAL EMERGENCY HAND CRANK
- QUANTUM CONSOLE MODULE
- QUANTUM DIAGNOSTIC EXHAUST
- QUANTUM DIAGNOSTIC MODULE
- QUANTUM MICRO-CARDIOPLEGIA DELIVERY MODULE
- QUANTUM MINI VENTILATION MODULE
- QUANTUM POWER SUPPLY
- QUANTUM PRESSURE SENSOR ASSY
- QUANTUM PRESSURE SENSOR ASSY (GEN 2)
- QUANTUM ROLLER PUMP
- QUANTUM SMART OCCLUDER
- QUANTUM VENTILATION LITE
- QUANTUM VENTILATION MODULE
- QUANTUM WORKSTATION
- RESERVOIR LEVEL SENSOR
- SENSOR SPSE01 FLOW
- SENSOR SPSE02 FLOW
- SENSOR SPSE03 FLOW
- SENSOR SPSE04 FLOW
- SENSOR SPSE05 FLOW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.