Medical device licence · 13604 · Class 3
AURORA PLASMAPHERESIS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 27, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 13604
- Licence holder
- Fresenius Kabi AgBad Homburg, Hessen, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 27, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AURORA 1.3 UPGRADE
- AURORA 2.0 UPGRADE
- AURORA 2.1 UPGRADE KIT
- AURORA APHERESIS SYSTEM (REFURBISHED)
- AURORA PLASMAPHERESIS SYSTEM
- AUTOPHERESIS-C
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.