Medical device licence · 113480 · Class 2
ACCESS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 10, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113480
- Licence holder
- Route 92 Medical, IncSan Mateo, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 10, 2025
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 070 ACCESS SYSTEM
- 088 ACCESS SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.