Medical device licence · 488 · Class 3
PERITONEAL DIALYSIS CYCLER UNITS
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed January 7, 1999; ended October 31, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 488
- Licence holder
- Fresenius Usa, Inc.Concord, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- January 7, 1999
- Ended
- October 31, 2018
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FREEDOM CYCLER
- FREEDOM CYCLER PD+
- FRESENIUS PD IQCARD CYCLER
- FRESENIUS PD PLUS PERITONEAL CYCLER SYSTEM
- NEWTON IQ CYCLER SYSTEM
- NEWTON IQ CYCLER SYTEM - REFURBISHED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.