Medical device licence · 78119 · Class 4
PENUMBRA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 9, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 78119
- Licence holder
- Penumbra Inc.Alameda, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 9, 2008
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PENUMBRA SYSTEM - ASPIRATION PUMP
- PENUMBRA SYSTEM - ASPIRATION TUBING
- PENUMBRA SYSTEM - MAX ASPIRATION TUBING
- PENUMBRA SYSTEM - NON-STERILE PUMP SUPPLIES
- PENUMBRA SYSTEM - REPERFUSION CATHETER
- PENUMBRA SYSTEM - REPERFUSION CATHETER + PENUMBRA HI-FLOW ASPIRATON TUBING
- PENUMBRA SYSTEM - SEPARATOR
- PENUMBRA SYSTEM - SEPARATOR 3D
- PENUMBRA SYSTEM - SEPARATOR FLEX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.