Medical device licence · 82092 · Class 3
U500 URINE ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed February 22, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82092
- Licence holder
- Btnx Inc.Pickering, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- February 22, 2010
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISTINCT U500 URINE ANALYZER
- DISTINCT U500 URINE ANALYZER WITH BARCODE READER
- INSIGHT U500 URINE ANALYZER
- INSIGHT U500 URINE ANALYZER WITH BARCODE READER
- MISSION U500 URINE ANALYZER
- MISSION U500 URINE ANALYZER WITH BARCODE READER
- VERIFY U500 URINE ANALYZER
- VERIFY U500 URINE ANALYZER WITH BARCODE READER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.