ApprovalTrail

Medical device licence · 98157 · Class 2

SCOPIS NAVIGATION SYSTEMS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed December 1, 2016; ended September 30, 2020. It is in Health Canada’s archive of licences no longer in force.
Licence number
98157
Licence holder
Scopis GmbhBerlin, 11, Germany
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
December 1, 2016
Ended
September 30, 2020
Devices covered
22

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • SCOPIS CALIBRATION BODY
  • SCOPIS CALIBRATION TARGET
  • SCOPIS ELBOW FOR INSTRUMENT CLAMP
  • SCOPIS ENDOSCOPE TRACKER
  • SCOPIS FIELD GENERATOR MOUNTING ARM
  • SCOPIS FIELD GENERATOR PLANAR
  • SCOPIS HEADBAND AND FOAM PAD
  • SCOPIS HEADREST FOR EM NAVIGATION
  • SCOPIS HYBRID NAVIGATION UNIT
  • SCOPIS INSTRUMENT CLAMP
  • SCOPIS INSTRUMENT TRACKER
  • SCOPIS MAYFIELD TRACKER
  • SCOPIS NOVA AR
  • SCOPIS NOVA PLAN
  • SCOPIS PATIENT TRACKER
  • SCOPIS PATIENT TRACKER TABS
  • SCOPIS POINTER
  • SCOPIS POSITION SENSOR VICRA
  • SCOPIS SKULL TRACKER
  • SCOPIS STAND FOR POSITION SENSOR VICRA
  • SCOPIS SUCTION TUBE
  • SCOPIS UNIVERSAL TRACKER

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.