Medical device licence · 84064 · Class 3
GEM FLOW COUPLER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 6, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84064
- Licence holder
- Synovis Micro Companies Alliance, Inc. (A Subsidiary Of Baxter International Inc.)Birmingham, AL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 6, 2010
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GEM FLOW COUPLER - DEVICE
- GEM FLOW COUPLER - MONITOR
- GEM FLOW COUPLER - POWER COMPONENTS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.