Medical device licence · 97733 · Class 3
ACCU-CHEK GUIDE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 4, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97733
- Licence holder
- Roche Diabetes Care GmbhBurgdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 4, 2016
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCU-CHEK GUIDE
- ACCU-CHEK GUIDE CONTROL
- ACCU-CHEK GUIDE TEST STRIPS
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
- Accu-Chek Guide (2019-10-24)November 15, 2019 · Medical devices · Medical devices · Type II
- Accu-Chek Aviva Test Strips (2018-05-07)May 25, 2018 · Medical devices · Medical devices · Type II
- Accu-Chek Inform II Test Strips (2018-05-07)May 25, 2018 · Medical devices · Medical devices · Type II
- Accu-Chek Connect Diabetes Management AppJuly 17, 2017 · Medical devices · Type II
- Accu-Chek Mobile Test-CassetteJune 5, 2017 · Medical devices · Type III
- ACCU-CHEK AVIVA CONNECTNovember 15, 2016 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.