Medical device licence · 38691 · Class 3
SERENA
No longer licensed: cancelled
Licence status Cancelled; first licensed June 3, 2002; ended March 16, 2022. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 38691
- Licence holder
- Gambro Lundia AbLund, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 3, 2002
- Ended
- March 16, 2022
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SERENA
- SERENA - SOFTWARE 5.01
- SERENA - SOFTWARE 8.XX
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “serena”. A notice may cover another product or only some lots: read it to see what it covers.
- Pristina Serena (SenoAxys) (2019-05-19)May 31, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.