Medical device licence · 109539 · Class 2
HEMOSURE ACCU-READER A100
Yes: licensed in Canada
Licence status Issued (active); first licensed June 16, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109539
- Licence holder
- W.H.P.M. Bioresearch & Technology Co., Ltd.Beijing, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 16, 2023
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FECAL OCCULT BLOOD TEST CONTROL KIT
- HEMOSURE ACCU-READER A100
- HEMOSURE ACCU-READER A100 FIT TEST CARTRIDGE
- HEMOSURE ACCU-READER A100 HOME COLLECTION KITS MAILER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.