Medical device licence · 111414 · Class 2
MONARCH PLATFORM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 21, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111414
- Licence holder
- Auris Health IncorporatedSanta Clara, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 21, 2024
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOPSY FORCEPS - SMOOTH CUP
- BRONCHOSCOPE FLUIDICS TUBING
- BRONCHOSCOPE PATIENT INTRODUCER KIT
- BRONCHOSCOPE SHEATH VALVE
- CYTOLOGY BRUSH
- MONARCH ADVANCED IMAGING ACCESSORY KIT
- MONARCH BRONCHOSCOPE
- MONARCH CONTROLLER
- MONARCH NAVIGATION PATIENT SENSORS
- MONARCH PLATFORM
- MONARCH PRE-OP PLANNING SYSTEM KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.