Medical device licence · 104009 · Class 2
TRIUX NEO
Yes: licensed in Canada
Licence status Issued (active); first licensed December 9, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 104009
- Licence holder
- Megin OyEspoo, Finland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 9, 2019
- Devices covered
- 34
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 128-CHANNEL EEG CAP PACKAGE
- 128-CHANNEL EEG HEADBOX
- 32-CHANNEL EEG CAP PACKAGE
- 64-CHANNEL EEG CAP PACKAGE
- ACQUISITION SYSTEM UPS
- ANALYSIS WORKSTATION
- ASSEMBLY ELECTRICAL STIMULATOR
- ASSEMBLY HIGH-FIDELITY VISUAL STIMULATOR
- ASSEMBLY INTERCOM SYSTEM
- ASSEMBLY MIRROR SYSTEM, SUPINE
- ASSEMBLY PROJECTOR MIRROR
- ASSEMBLY VIDEO MONITORING SYSTEM
- AUDIO STIMULATOR EARPHONES
- CHAIR FINE-ADJUSTMENT SYSTEM
- COLOR PRINTER
- DATA ACQUISITION SOFTWARE
- DATA ANALYSIS SOFTWARE
- EXTERNAL ACTIVE SHIELDING
- FINGER RESPONSE PAD
- FIREWALL
- HPI COIL SET
- INTERNAL HELIUM RECYCLER
- MAXFILTER
- MAXSHIELD
- PEDIATRIC COMFORT SET
- ROOM OXYGEN LEVEL MONITOR
- STIMULUS PRESENTATION WS
- THREE-LAYER MAGNETIC SHIELD
- TRIUX NEO
- TRIUX NEO CHAIR
- TRIUX NEO PATIENT COUCH
- TWO-LAYER MAGNETIC SHIELD
- VISUAL STIMULUS CALIBRATION UNIT
- WORKSTATION UPS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.