Medical device licence · 106324 · Class 4
MIRASOL PATHOGEN REDUCTION TECHNOLOGY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 29, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106324
- Licence holder
- Terumo Bct, Inc.Lakewood, Colorado, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- June 29, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MIRASOL DOUBLE+ PLATELET DISPOSABLE KIT FOR TREATMENT IN PLASMA
- MIRASOL ILLUMINATOR
- MIRASOL MANAGER
- MIRASOL PLATELET DISPOSABLE KIT FOR TREATMENT IN PLASMA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.