Medical device licence · 112267 · Class 3
AMICUS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 25, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 112267
- Licence holder
- Fresenius Kabi AgBad Homburg, Hessen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 25, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMICUS EXTRACORPOREAL PHOTOPHERESIS (ECP) APHERESIS KIT
- AMICUS SEPARATOR
- AMICUS SEPARATOR SOFTWARE
- PHELIX PHOTOACTIVATION DEVICE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.