Medical device licence · 100113 · Class 2
SPIROSPHERE
Yes: licensed in Canada
Licence status Issued (active); first licensed November 30, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 100113
- Licence holder
- Eresearch Technology GmbhEstenfeld, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 30, 2017
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ERT PT
- SPIROSPHERE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.