Medical device licence · 107066 · Class 3
HUGO ROBOTICALLY ASSISTED SURGERY (RAS) SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 3, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 107066
- Licence holder
- Covidien LlcChicopee, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 3, 2021
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HUGO RAS 3D GLASSES, SURGEON ONLY
- HUGO RAS ARM CART ASSEMBLY
- HUGO RAS BIPOLAR FENESTRATED GRASPER
- HUGO RAS BIPOLAR MARYLAND FORCEPS
- HUGO RAS CADIERE FORCEPS
- HUGO RAS DOUBLE FENESTRATED GRASPER
- HUGO RAS ENDOSCOPE ADAPTER
- HUGO RAS EXTRA LARGE NEEDLE DRIVER
- HUGO RAS LARGE NEEDLE DRIVER
- HUGO RAS MONOPOLAR CURVED SHEARS
- HUGO RAS MONOPOLAR TIP COVER
- HUGO RAS SECURE CADIERE FORCEPS
- HUGO RAS STERILE INTERFACE MODULE
- HUGO RAS SURGEON CONSOLE
- HUGO RAS TOOTHED GRASPER
- HUGO RAS TOWER, 120V
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.