Medical device licence · 90503 · Class 3
LUMINEX FLEXMAP 3D
Yes: licensed in Canada
Licence status Issued (active); first licensed January 11, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 90503
- Licence holder
- Luminex CorporationAustin, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 11, 2013
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLEXMAP 3D CALIBRATION KIT
- FLEXMAP 3D PERFORMANCE VERIFICATION KIT
- LUMINEX FLEXMAP 3D INSTRUMENT
- LUMINEX XPONENT SOFTWARE
- XMAP SHEATH CONCENTRATE PLUS
- XMAP SHEATH FLUID
- XMAP SHEATH FLUID PLUS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.