Medical device licence · 101981 · Class 2
QUARK RMR
Yes: licensed in Canada
Licence status Issued (active); first licensed October 29, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101981
- Licence holder
- Cosmed S.R.L.Albano Laziale, RM, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 29, 2018
- Devices covered
- 58
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 18 ID RMR FLOWMETER, QUARK 2007
- 2 WAYS VALVE ASSEMBLY
- 2-WAY NON-BREATHING VALVE
- 28 ID DIGITAL FLOWMETER
- ADULT ARTICULATED FINGER CLIP SENSOR
- ANT HR MODULE GARMIN
- ANTIBACTERIAL FILTERS
- CANOPY BUBBLEHOOD
- CARDIAC OUTPUT ADAPTER
- CONICAL MOUTHPIECE
- CPET OPTION FOR QRMR
- EAR CLIP SENSOR
- EVITAXL\SERVO-I VENT. ADAPTER
- FACE MASK READER CONNECTOR
- FILTER FOR SAMPLING LINE
- FLOW-REE
- HEAD SUPPORT FOR 2 WAYS VALVE
- HR ANT USB PROBE
- ICU ADAPTER FOR RMR FLOWMETER
- ICU CONNECTOR
- ICU FILTER HMEF W\ LUER LOCK
- ICU KIT W/FLOWREE
- ICU, SAMPLING ADAPTER
- ID25MM SOFT MOUTHPIECE
- MASK ADAPTER
- MIXING CHAMBER UNIT
- MIXING CHAMBER 2015
- MIXING CHAMBER 2015 UPGRADE KIT (REQUIRES OMNIA)
- MIXING CHAMBER KIT
- MIXING CHAMBER TUBE HOLDER
- NELLCORE PB VENTILATOR ADAPTER
- NOSE CLIPS
- OMNIA
- OMNIA - REE MODULE MASK
- OMNIA AUX DEVICES
- OMNIA ERGOMETERS DRIVERS
- OMNIA REVIEW STATION
- OMNIA SOFTWARE
- OMNIA, SPIROMETRY MODULE
- OXIMETER XPOD, CPET/PFT
- PEDIATRIC FINGER CLIP SENSOR
- PNT EXTENSION TUBE
- PTE MOLDED ADAPTER
- QRMR, ICU MODULE
- QUARK RMR
- QUARK RMR UNIT
- REFLECTANCE SENSOR
- RMR FLOWMETER ADAPTER
- RMR TUBE O2/CO2
- SPIROMETRY MOUTHPIECE ADAPTER
- SW CPET & PFT
- SW CPET + ACTIVATION CODE
- T/RH PROBE PFT2007
- TAEMA EXTEND X VENT. ADAPTER
- TURBINE PLUG, MIXING CHAMBER
- V2 MASK ADULT
- V2 MASK FOR VO2MAX FLOWMETER
- V2 MASK PAEDIATRIC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.