Medical device licence · 62864 · Class 3
TANDEM BIPOLAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 31, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 62864
- Licence holder
- Smith & Nephew, Inc.Mississauga, Ontario, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- July 31, 2003
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COCR TANDEM BIPOLAR SHELL/LINER
- TANDEM INTL BIPOLAR SHELL/LINER
- TANDEM TRIAL SHELL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.