Medical device licence · 88998 · Class 3
STAT PROFILE PHOX ULTRA SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 11, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 88998
- Licence holder
- Nova Biomedical CorporationWaltham, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 11, 2012
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STAT PROFILE PHOX ULTRA SYSTEM - ANALYZER
- STAT PROFILE PHOX ULTRA SYSTEM - BLANK
- STAT PROFILE PHOX ULTRA SYSTEM - BLOOD GAS CONTROLS AUTO CARTRIDGE
- STAT PROFILE PHOX ULTRA SYSTEM - CALIBRATOR CARTRIDGE
- STAT PROFILE PHOX ULTRA SYSTEM - CAP KIT
- STAT PROFILE PHOX ULTRA SYSTEM - CHEMISTRY CONTROLS AUTO CARTRIDGE
- STAT PROFILE PHOX ULTRA SYSTEM - CO-OX CONTROLS AUTO CARTRIDGE
- STAT PROFILE PHOX ULTRA SYSTEM - CONTROL AMPULE(S)
- STAT PROFILE PHOX ULTRA SYSTEM - DEPROTEINIZING SOLUTION
- STAT PROFILE PHOX ULTRA SYSTEM - LINEARITY SOLUTION SET
- STAT PROFILE PHOX ULTRA SYSTEM - MEMBRANE KIT
- STAT PROFILE PHOX ULTRA SYSTEM - SENSOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.