ApprovalTrail

Medical device licence · 114543 · Class 2

ISIS SYSTEMS

Yes: licensed in Canada

Licence status Issued (active); first licensed December 22, 2025. It is in Health Canada’s list of active licences.
Licence number
114543
Licence holder
Inomed Medizintechnik GmbhEmmendingen, 08, Germany
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
December 22, 2025
Devices covered
32

Devices on this licence

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

  • ADAPTER CABLE CABLE LENGTH 1.5M
  • ADAPTOR CABLE DNS CABLE LENGTH 2M
  • CABLE FOR 5 CHANNEL MER FOR FHC AND IMM ELECTRODES
  • CABLE FOR 5 CHANNEL MER FOR MICRO AND MACRO ELECTRODES
  • EMG/MEP-ADAPTOR CH. 1-8 FOR 504271 FOR COLOR-CODED ACCESSORIES
  • EMG/MEP-ADAPTOR CH. 1-8 FOR 504271 FOR ISIS HEADBOX 16CH. DIF
  • EMG/MEP-ADAPTOR CH. 9-16 FOR 504271 FOR ISIS HEADBOX 16CH. DIF
  • EP ADAPTOR FOR ISIS HEADBOX 16CH. REF
  • EP ADAPTOR FOR ISIS HEADBOX 16CH.REF-AEP
  • EP ADAPTOR FOR ISIS HEADBOX 8CH.DIF-8CH.REF-AEP
  • EP ADAPTOR FOR ISIS HEADBOX 8CH.DIF-8CH.REF-AEP
  • EXTENSION CABLE CABLE LENGTH 2M
  • GRID/TES STIMULATION MATRIX 16 CH. FOR ISIS NEUROSTIMULATOR
  • GRID/TES STIMULATION MATRIX 8 CH. FOR ISIS NEUROSTIMULATOR
  • ISIS HEADBOX 16 CH. DIF
  • ISIS HEADBOX 16CH. REF
  • ISIS HEADBOX 16CH. REF-AEP
  • ISIS HEADBOX 8 CH. DIF - 8 CH. REF - AEP
  • ISIS HEADBOX U5S MER
  • ISIS MER PORTABLE SYSTEM
  • ISIS NEUROSTIMULATOR
  • ISIS SYSTEM BASE UNIT
  • ISIS XPERT PLUS SYSTEM
  • ISIS XPERT SYSTEM
  • ISIS XPRESS DOCKING STATION
  • ISIS XPRESS SYSTEM
  • MEP STIMULATION ADAPTOR FOR GRID/TES STIMULATION MATRIX
  • PIOM BOX FOR 504271/504285
  • SEP STIMULATION ADAPTOR FOR ISIS NEUROSTIMULATOR
  • STIMULATION ADAPTOR FOR ISIS NEUROSTIMULATOR
  • STIMULATION CABLE CABLE LENGTH 4M
  • STIMULATION PROBE CABLE CABLE LENGTH 4M

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