Medical device licence · 95939 · Class 2
K5
Yes: licensed in Canada
Licence status Issued (active); first licensed October 26, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95939
- Licence holder
- Cosmed S.R.L.Albano Laziale, RM, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 26, 2015
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANT+ ENGINE MODULE
- BATTERY CHARGER
- BATTERY PACK, K5
- CHARGE UNIT BATTERY, K5
- CO2 ABSORBER, K5
- HR BELT COSMED-ANT+
- HR MONITOR COSMED-ANT+
- HR POLAR RECEIVER
- INTELLIMET BXB GAS SAMPLING MODULE
- K5
- K5 TURBINE W/CASE
- K5 UNIT
- K5 USB CABLE
- LONG DISTANCE BLUETOOTH MODULE
- MOUTHPIECE ADAPTER SPIROMETER
- O2 GFC SENSOR
- OMNIA
- OMNIA AUX DEVICES
- OMNIA SOFTWARE
- OMNIA, SPIROMETRY MODULE
- OPTO-READER, K5
- OPTOISOLATED HR INTERFACE
- POWER SUPPLY, K5
- SAMPLING LINE
- USA PLUG FOR POWER SUPPLY
- V2 MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.