Medical device licence · 2361 · Class 3
COAGUCHEK
No longer licensed: cancelled
Licence status Cancelled; first licensed April 20, 1999; ended December 8, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 2361
- Licence holder
- Roche Diagnostics GmbhMannheim, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 20, 1999
- Ended
- December 8, 2015
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COAGUCHEK SYSTEM - CONTROLS 2 LEVELS
- COAGUCHEK SYSTEM - CONTROLS 2 LEVELS (4)
- COAGUCHEK SYSTEM - EQC
- COAGUCHEK SYSTEM - METER
- COAGUCHEK SYSTEM - METER
- COAGUCHEK SYSTEM - PT S
- COAGUCHEK SYSTEM - PT S CONTROLS
- COAGUCHEK SYSTEM - PT TEST
- COAGUCHEK SYSTEM - PT TEST (12)
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 “coaguchek”. A notice may cover another product or only some lots: read it to see what it covers.
- Coaguchek XS Strips (2018-10-10)November 28, 2018 · Medical devices · Medical devices · Type III
- CoaguChek XS Pro and Plus, Cobas H 232 Instruments (2017-12-18)January 29, 2018 · Medical devices · Medical devices · Type II
- COAGUCHEK SOFTCLIX LANCING DEVICESeptember 7, 2016 · Medical devices · Type III
- COAGUCHEK XS PLUS MONITORS ( 2015-07-23)August 18, 2015 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.