Medical device licence · 77166 · Class 2
IGUIDE SYSTEM
No longer licensed: cancelled: renewal not answered
Licence status Cancelled: renewal not answered; first licensed May 23, 2008; ended October 31, 2016. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 77166
- Licence holder
- 3C-Medical Intelligence GmbhLandsberg Am Lech, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 23, 2008
- Ended
- October 31, 2016
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IGUIDE SYSTEM - CABLE SET
- IGUIDE SYSTEM - CALIBRATION TOOL SET
- IGUIDE SYSTEM - IGUIDE 2.X CABLE SET
- IGUIDE SYSTEM - IGUIDE 2.X INCL. WORKSTATION
- IGUIDE SYSTEM - MANUAL SET
- IGUIDE SYSTEM - REFERENCE FRAME SET
- IGUIDE SYSTEM - SOFTWARE RELEASE 1.1 REV.1
- IGUIDE SYSTEM - TERMINAL
- IGUIDE SYSTEM - TRACKING SYSTEM
- IGUIDE SYSTEM - WORKSTATION
- IGUIDE SYSTEM - WORKSTATION MONITOR
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 “iguide”. A notice may cover another product or only some lots: read it to see what it covers.
- IGUIDE SOFTWARE 2.X INCLUDING WORKSTATION (2019-07-16)August 2, 2019 · Medical devices · Medical devices · Type II
- iGUIDE Tracking System (2019-06-20)July 5, 2019 · 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.