Medical device licence · 101947 · Class 3
ROSA ONE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 25, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101947
- Licence holder
- Medtech SasWilson, Wyoming, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 25, 2018
- Devices covered
- 26
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3D X-RAY PATTERN
- 3D X-RAY PATTERN PHANTOM
- AWL
- CANNULA
- FRAME BASED MODULE
- GUIDE WIRE NAVIGATION REFERENCE
- MICRODRIVE HOLDER
- NAVIGATION QUICKLOCK REFERENCE RED
- NAVIGATION QUICKLOCK REFERENCE YELLOW
- OPTICAL DISTANCE SENSOR
- PERCUTANEOUS PIN
- PIN CAP
- PLANNING STATION
- POINTER PROBE
- ROBOT ARM REFERENCE
- ROSA ONE (CA)
- ROSA ONE NAVIGATION PROBE
- SOFTWARE FOR PLANNING POSITIONS AND NAVIGATING INSTRUMENTS FOR BRAIN APPLICATION
- SOFTWARE FOR PLANNING POSITIONS AND NAVIGATING INSTRUMENTS FOR SPINE APPLICATION
- SPINOUS CLAMP LONG
- SPINOUS CLAMP SHORT
- STERILE BALL HEX ALLEN WRENCH
- STERILE BALL HEX DRIVER
- STERILE ROBOT ARM INTERFACE
- UNIVERSAL NAVIGATION REFERENCE
- VENTRICULAR ENDOSCOPY MODULE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.