Medical device licence · 70207 · Class 2
ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed January 16, 2006; ended January 2, 2013. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 70207
- Licence holder
- Thermo Fisher Scientific Inc.Beverly, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- January 16, 2006
- Ended
- January 2, 2013
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENGEN
- ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
- ENGEN1
- ENGEN2
- ENGEN3
- ENGEN4
- ENGEN5
- ENGEN6
- ENGEN9
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 “engen”. A notice may cover another product or only some lots: read it to see what it covers.
- Engen Laboratory Automation SystemJune 5, 2017 · Medical devices · Type III
- Engen Laboratory Automation SystemMarch 31, 2017 · Medical devices · Type II
- enGen Laboratory Automation SystemSeptember 8, 2016 · Medical devices · Medical devices · Type II
- enGen Laboratory Automation System (2016-03-18)April 7, 2016 · Medical devices · Medical devices · Type II
- ENGEN LABORATORY AUTOMATION SYSTEM (2015-05-07)June 3, 2015 · Medical devices · Health products · Type II
- ENGEN LABORATORY AUTOMATION SYSTEM (2015-04-07)May 6, 2015 · Medical devices · Health products · Type II
- Engen Automated Sample Handling System (2014-04-11)April 30, 2014 · Medical devices · Medical devices · Type II
- EnGen Laboratory Automation System (2014-03-21)April 14, 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.