Medical device licence · 79878 · Class 3
STATSENSOR CREATININE METER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 3, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79878
- Licence holder
- Nova Biomedical CorporationWaltham, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 3, 2009
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STAT SENSOR CREAT CONTROL LEVEL 1
- STAT SENSOR CREAT CONTROL LEVEL 2
- STAT SENSOR CREAT CONTROL LEVEL 3
- STATSENSOR CREATININE METER WITH BATTERY AND QUICK REFERENCE GUIDE
- STATSENSOR STATSTRIP DOCKING STATION
- STATSENSOR-CREATININE LINEARITY KIT
- STATSENSOR-CREATININE TEST STRIPS
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “statsensor”. A notice may cover another product or only some lots: read it to see what it covers.
- Statstrip Meter System and Statsensor Creatinine Hospital Meter Kit (2013-11-22)January 6, 2014 · Medical devices · Medical devices · Type III
- Nova StatStrip and Nova StatSensorJanuary 7, 2013 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.