Medical device licence · 105595 · Class 3
ACCU-CHEK GUIDE LINK SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 11, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105595
- Licence holder
- Roche Diabetes Care GmbhBurgdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 11, 2020
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCU-CHEK GUIDE LINK METER
- ACCU-CHEK GUIDE TEST STRIPS 10 CT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “accu-chek”. A notice may cover another product or only some lots: read it to see what it covers.
- Accu-Chek GuideSeptember 26, 2024 · Gastroenterology and urology · Labelling and packaging - Performance · Type II
- ACCU-CHEK INFORM II TEST STRIPS (2021-07-22)August 19, 2021 · Medical devices · Medical devices · Type II
- ACCU-CHEK AVIVA-TEST STRIPS (2021-07-23)August 19, 2021 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.