Medical device licence · 115037 · Class 2
FASTEP COLLOIDAL IMMUNOASSAY ANALYZER
Yes: licensed in Canada
Licence status Issued (active); first licensed March 10, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115037
- Licence holder
- Assure Tech. (Hangzhou) Co. Ltd.Hangzhou, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- March 10, 2026
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FASTEP COLLOIDAL IMMUNOASSAY ANALYZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.