Medical device licence · 84215 · Class 2
NICOLET EDX
Yes: licensed in Canada
Licence status Issued (active); first licensed October 18, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84215
- Licence holder
- Natus Neurology IncorporatedMiddleton, WI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 18, 2010
- Devices covered
- 24
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMG USB CONTROL PANEL II WITH CABLE
- EMG USB CONTROL PANEL USB II
- NATUS ELITE V2 SOFTWARE - READER SOFTWARE
- NATUS ELITE V2 SOFTWARE - SYNERGY
- NATUS ELITE V2 SOFTWARE - SYNERGY & VIKING COMBO
- NATUS ELITE V2 SOFTWARE - UPDATE
- NATUS ELITE V2 SOFTWARE - UPGRADE
- NATUS ELITE V2 SOFTWARE - UPGRADE WITH NEW SYSTEM ORDER
- NATUS ELITE V2 SOFTWARE - VIKING
- NATUS ELITE V2.0 INSTALL MEDIA
- NATUS VISUAL STIMULATOR
- NATUS VISUAL STIMULATOR OPTION WITH MONITOR
- NATUS VISUAL STIMULATOR OPTION WITHOUT MONITOR
- NICOLET EDX SYSTEM
- NICOLET EDX SYSTEM - AMPLIFIER OPTIONS
- NICOLET EDX SYSTEM - CONTROL PANEL
- NICOLET EDX SYSTEM - ELECTRODE STARTER KITS
- NICOLET EDX SYSTEM - FOOT SWITCH
- NICOLET EDX SYSTEM - ISOLATION POWER SUPPLY
- NICOLET EDX SYSTEM - MOVEMENT SENSOR
- NICOLET EDX SYSTEM - POWER CORD KIT
- NICOLET EDX SYSTEM - SOFTWARE
- NICOLET EDX SYSTEM - STIMULATOR OPTIONS
- NICOLET EDX SYSTEM - TEMPERATURE PROBE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.