Medical device licence · 109926 · Class 3
ROTEM SIGMA
Yes: licensed in Canada
Licence status Issued (active); first licensed August 24, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109926
- Licence holder
- Tem Innovations GmbhMunich, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 24, 2023
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ROTEM SIGMA
- ROTEM SIGMA COMPLETE
- ROTEM SIGMA COMPLETE + HEP
- ROTEM SIGMA ROTROL N
- ROTEM SIGMA ROTROL P
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.