Medical device licence · 61349 · Class 3
DIALOG PC SOFTWARE
No longer licensed: cancelled
Licence status Cancelled; first licensed January 3, 2003; ended June 22, 2010. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61349
- Licence holder
- Roche Diabetes Care GmbhBurgdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- January 3, 2003
- Ended
- June 22, 2010
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIALOG PC-SW
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 “dialog”. A notice may cover another product or only some lots: read it to see what it covers.
- Dialog+ Dialysis machiines and Option Adimea with Software 8.2A (2016-10-11)October 11, 2016 · Medical devices · Medical devices · Type II
- Dialog+ Dialysis Machines (2016-03-18)May 26, 2016 · Medical devices · Medical devices · Type I
- Dialog+ SW 9.XX (2015-11-18)January 7, 2016 · Medical devices · Health products · Type III
- Dialog+ SW 9.XX (2015-11-18)November 18, 2015 · Medical devices · Health products · Type III
- Dialog+ SW 9.XX Two Pump Machines (incl. HDF online) (2014-11-17)November 26, 2014 · 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.