Medical device licence · 110205 · Class 2
OCS LIVER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 24, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110205
- Licence holder
- Transmedics, Inc.Andover, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 24, 2023
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BILE CANNULA
- OCS LIVER BILE SALTS SET
- OCS LIVER CONSOLE
- OCS LIVER INSTRUMENTATION TOOL SET
- OCS LIVER PERFUSION INITIATION SET
- OCS LIVER PERFUSION SET
- OCS LIVER PERFUSION TERMINATION SET
- OCS LIVER SOLUTION INFUSION SET
- SOLUTION DELIVERY CASSETTES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.