ApprovalTrail

Medical device licence · 97635 · Class 2

FSH RAPID TEST DEVICE (URINE)

Yes: licensed in Canada

Licence status Issued (active); first licensed August 30, 2016. It is in Health Canada’s list of active licences.
Licence number
97635
Licence holder
Assure Tech. (Hangzhou) Co. Ltd.Hangzhou, 130, China
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
August 30, 2016
Devices covered
1

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • FSH RAPID TEST DEVICE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.