Medical device licence · 107733 · Class 2
SPIROSPHERE ECG
Yes: licensed in Canada
Licence status Issued (active); first licensed May 5, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107733
- Licence holder
- Eresearch Technology GmbhEstenfeld, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 5, 2022
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPIROSPHERE ECG
- TYPE ECG UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.