Medical device licence · 112731 · Class 2
SAME BY I-SEP
Yes: licensed in Canada
Licence status Issued (active); first licensed February 18, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 112731
- Licence holder
- I-SepNantes, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 18, 2025
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASPIRATION AND ANTICOAGULATION LINE
- AUTOTRANSFUSION SYSTEM
- BLOOD COLLECTION RESERVOIR
- I-SEP AUTOTRANSFUSION TREATMENT SET
- I-SEP MICRO-AGGREGATES CHAMBER
- I-SEP REINFUSION BAG
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.