Medical device licence · 78596 · Class 2
U500 URINE ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed December 5, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 78596
- Licence holder
- Btnx Inc.Pickering, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- December 5, 2008
- 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.