Medical device licence · 108364 · Class 2
OC-SENSOR FIT
Yes: licensed in Canada
Licence status Issued (active); first licensed October 10, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108364
- Licence holder
- Eiken Chemical Co., Ltd.Chiyoda-Ku, 13, Japan
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 10, 2022
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OC-AUTO SAMPLING BOTTLE 3
- OC-FIT CALIBRATOR
- OC-FIT CONTROL
- OC-SENSOR FIT BUFFER
- OC-SENSOR FIT LATEX REAGENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.