Medical device licence · 113436 · Class 2
DIGITAL FERTILITY TESTING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 4, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113436
- Licence holder
- Assure Tech. (Hangzhou) Co. Ltd.Hangzhou, 130, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 4, 2025
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIGITAL FERTILITY TESTING SYSTEM, ECOTEST
- DIGITAL FERTILITY TESTING SYSTEM, FASTEP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.