Medical device licence · 104725 · Class 2
QUANTUM HEATER-COOLER
Yes: licensed in Canada
Licence status Issued (active); first licensed June 4, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104725
- Licence holder
- Spectrum Medical SrlGloucester, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 4, 2020
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARDIOPLEGIA HEAT EXCHANGER HIGH FLOW 1/4
- CARDIOPLEGIA HEAT EXCHANGER LOW FLOW 1/4
- CARDIOPLEGIA HEAT EXCHANGER LOW FLOW 1/4-PL
- CARDIOPLEGIA HEAT EXCHANGER LOW FLOW 3/16
- CARDIOPLEGIA HEAT EXCHANGER LOW FLOW 3/16-PL
- COOLFLOW SM-03-DTX
- QUANTUM HEATER-COOLER
- STANDARD HEAT EXCHANGER HIGH FLOW 3/8
- STANDARD HEAT EXCHANGER LOW FLOW 1/4
- STANDARD HEAT EXCHANGER LOW FLOW 3/16
- STANDARD HEAT EXCHANGER MEDIUM FLOW 1/4
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.