Medical device licence · 98198 · Class 2
CALYPSO
Yes: licensed in Canada
Licence status Issued (active); first licensed December 8, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98198
- Licence holder
- Ardo Medical AgUnterageri, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 8, 2016
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALYPSO
- CALYPSO DOUBLE PLUS
- CALYPSO ESSENTIALS
- CALYPSO PUMP UNIT
- CALYPSO TO-GO
- CLINIC PUMPSET
- DOUBLE CLINIC PUMPSET
- DOUBLE PUMPSET
- EASY FREEZE
- OPTIFLOW
- SINGLE PUMPSET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.