Medical device licence · 113067 · Class 2
NOVA PRIMARY GLUCOSE ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed April 8, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113067
- Licence holder
- Nova Biomedical CorporationWaltham, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 8, 2025
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NOVA PRIMARY
- NOVA PRIMARY AMPULED CONTROL
- NOVA PRIMARY CALIBRATOR CARTRIDGE 150 SAMPLE
- NOVA PRIMARY CALIBRATOR CARTRIDGE 450 SAMPLE
- NOVA PRIMARY GLUCOSE MEMBRANE
- NOVA PRIMARY GLUCOSE SENSOR
- NOVA PRIMARY LINEARITY LEVEL 1
- NOVA PRIMARY LINEARITY LEVEL 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.