Medical device licence · 113447 · Class 3
BIOMONITOR IV
Yes: licensed in Canada
Licence status Issued (active); first licensed June 5, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113447
- Licence holder
- Biotronik Se & Co. KgBerlin, 11, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 5, 2025
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOMONITOR IV
- REMOTE ASSISTANT III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.