Medical device licence · 3257 · Class 3
ACCU-CHEK ACTIVE
No longer licensed: cancelled
Licence status Cancelled; first licensed June 10, 1999; ended March 9, 2005. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 3257
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 10, 1999
- Ended
- March 9, 2005
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCU-CHEK ACTIVE CONTROL SOLUTIONS
- ACCU-CHEK ACTIVE METER
- ACCU-CHEK ACTIVE TEST STRIPS
- GLUCOTREND SYSTEM - GLUCOTREND CONTROL G
- GLUCOTREND SYSTEM - GLUCOTREND MONITOR
- GLUCOTREND SYSTEM - GLUCOTREND STRIPS
- GLUCOTREND SYSTEM-GLUCOTREND CONTROL G
- GLUCOTREND SYSTEM-GLUCOTREND MONITOR
- GLUCOTREND SYSTEM-GLUCOTREND 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
- ACCU-CHEK CONNECT DIABETES MANAGEMENT APP (2016-04-19)April 29, 2016 · Medical devices · Medical devices · Type III
- ACCU-CHEK INFORM II + RF METER (2015-09-10)September 10, 2015 · Medical devices · Health products · Type III
- ACCU-CHEK INFORM II + RF METER (2015-05-29)July 8, 2015 · Medical devices · Health products · Type III
- ACCU-CHEK SPIRIT COMBO/ACCU-CHEK COMBO KIT (2015-04-15)May 8, 2015 · Medical devices · Health products · Type II
- ACCU-CHEK AVIVA METER (2015-03-17)April 30, 2015 · Medical devices · Health products · Type II
- Accu-Chek Spirit Combo Insulin Infusion Pump (2014-10-07)October 27, 2014 · Medical devices · Medical devices · Type II
- Accu-Chek Rapid-D Infusion Set (2014-09-17)September 25, 2014 · Medical devices · Medical devices · Type III
- Accu-chek Inform II + RF Meter (2014-08-25)September 3, 2014 · Medical devices · Medical devices · Type III
- Accu-chek Mobile Monitor (2014-05-29)August 8, 2014 · Medical devices · Medical devices · Type II
- Accu-Chek Mobile test cassette and test strips (2014-04-08)April 8, 2014 · Medical devices · Medical devices · Type II
- Accu-Chek Aviva Combo (2013-10-31)December 17, 2013 · Medical devices · Medical devices · Type II
- Archive - ACCU-CHEK Aviva Blood Glucose Meter - Advisories, Warnings and Recalls - For the PublicNovember 14, 2005 · Medical devices
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.