Medical device licence · 108009 · Class 2
SEMI-AUTOMATIC URINE ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed July 15, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108009
- Licence holder
- Arkray Factory, Inc.Koka, 25, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 15, 2022
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUTIONIDATEN AE-4070
- CHECK STRIP SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.