Medical device licence · 109342 · Class 2
FULLY AUTOMATIC KINETIC TUBE READER
Yes: licensed in Canada
Licence status Issued (active); first licensed May 15, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109342
- Licence holder
- Genobio Pharmaceutical Co., Ltd.Tianjin, 030, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 15, 2023
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FULLY AUTOMATIC KINETIC TUBE READER (IGL-200)
- IGL-200 BACTERIAL ENDOTOXIN DETECTION KIT
- IGL-200 FUNGUS (1-3)-BETA-D-GLUCAN DETECT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.