Medical device licence · 100426 · Class 3
STIMROUTER NEUROMODULATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 22, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100426
- Licence holder
- Bioventus LlcDurham, NC, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 22, 2018
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STIMROUTER CLINICIAN KIT
- STIMROUTER ELECTRODES
- STIMROUTER IMPLANTABLE LEAD AND LEAD INTRODUCER KIT
- STIMROUTER OAB LEAD IMPLANT KIT
- STIMROUTER OAB USER KIT
- STIMROUTER USER KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.