ApprovalTrail

Medical device licence · 103943 · Class 2

BRAINSCOPE ONE KIT

Yes: licensed in Canada

Licence status Issued (active); first licensed November 25, 2019. It is in Health Canada’s list of active licences.
Licence number
103943
Licence holder
Brainscope Company Inc.Rockville, MD, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
November 25, 2019
Devices covered
6

Devices on this licence

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

  • BRAINSCOPE BASELINE HEADSET
  • BRAINSCOPE ELECTRODE HEADSETS
  • BRAINSCOPE KIT - MODEL: AHEAD 500
  • BRAINSCOPE ONE EEG ACQUISITION UNIT
  • BRAINSCOPE ONE INTERNATIONAL CHARGING KIT
  • BRAINSCOPE ONE KIT

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