Medical device licence · 105149 · Class 3
STRYKER ENT NAVIGATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 16, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105149
- Licence holder
- Stryker Leibinger Gmbh & Co. KgKalamazoo, MI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 16, 2020
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALIBRATION BODY ELECTROMAGNETIC
- ELECTROMAGNETIC NAVIGATION UNIT
- ENDOSCOPE TRACKER ELECTROMAGNETIC
- FIELD GENERATOR
- INSTRUMENT CLAMP EM SPHERE
- INSTRUMENT CLAMP EM UNIVERSAL
- PATIENT TRACKER ELECTROMAGNETIC
- POINTER ELECTROMAGNETIC
- PRECISION POINTER ELECTROMAGNETIC
- REGISTRATION POINTER ELECTROMAGNETIC
- SCOPIS ENT SOFTWARE
- SCOPIS ENT SOFTWARE WITH TGS (TARGET GUIDED SURGERY)
- SUCTION TUBE EICKEN ELECTROMAGNETIC
- SUCTION TUBE FRAZIER ELECTROMAGNETIC
- UNIVERSAL TRACKER ELECTROMAGNETIC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.