Medical device licence · 94055 · Class 2
REVEOS AUTOMATED BLOOD PROCESSING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 9, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94055
- Licence holder
- Terumo Bct, Inc.Lakewood, Colorado, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 9, 2014
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PLATELET POOLING SET
- REVEOS 3 COMPONENT BLOOD BAG SET
- REVEOS AUTOMATED BLOOD PROCESSING SYSTEM
- REVEOS LR
- REVEOS LR EXT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.