Medical device licence · 111005 · Class 4
AMVIA SKY PACEMAKER
Yes: licensed in Canada
Licence status Issued (active); first licensed March 27, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111005
- Licence holder
- Biotronik Se & Co. KgBerlin, 11, Germany
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- March 27, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMVIA SKY DR-T
- AMVIA SKY HF-T
- AMVIA SKY HF-T QP
- AMVIA SKY SR-T
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.