Medical device licence · 104947 · Class 2
OCS LUNG SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 23, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104947
- Licence holder
- Transmedics, Inc.Andover, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 23, 2020
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OCS LUNG CONSOLE
- OCS LUNG PERFUSION SET
- OCS LUNG SOLUTION
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.