Medical device licence · 101623 · Class 2
STAT PROFILE PRIME PLUS ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed August 15, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101623
- Licence holder
- Nova Biomedical CorporationWaltham, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 15, 2018
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STAT PROFILE PRIME PLUS
- STAT PROFILE PRIME PLUS (REMANUFACTURED)
- STAT PROFILE PRIME PLUS MICROSENSOR CARD WITH COOX
- STAT PROFILE PRIME PLUS MICROSENSOR CARD WITH COOX 100
- STAT PROFILE PRIME PLUS MICROSENSORCARD WITH COOX (HIGH VOLUME)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.