Medical device licence · 106802 · Class 2
XPLEX
Yes: licensed in Canada
Licence status Issued (active); first licensed October 7, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106802
- Licence holder
- Candulor AgGlattpark (Opfikon), ZH, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 7, 2021
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- X PLEX F1
- X PLEX F3
- X PLEX F34
- X PLEX F5
- X PLEX F53
- X PLEX F55
- X PLEX F57
- X PLEX MONOMER COLD
- X PLEX MONOMER HOT
- X PLEX TRIAL SET F34
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.