Medical device licence · 81277 · Class 2
ACCU-CHEK SMART PIX DEVICE READER
Yes: licensed in Canada
Licence status Issued (active); first licensed November 23, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81277
- Licence holder
- Roche Diabetes Care GmbhBurgdorf, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 23, 2009
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCU-CHEK SMART PIX DEVICE READER
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
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.