Medical device licence · 105146 · Class 2
VOLUMAT LINE
Yes: licensed in Canada
Licence status Issued (active); first licensed September 14, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105146
- Licence holder
- Fresenius Kabi AgBad Homburg, Hessen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 14, 2020
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VL ON90, LIGHT-PROTECTED
- VL PN02-1 , 1.2 MICRON FILTER
- VL PR42-11
- VL PR42-12
- VL PR44-12
- VL PR72-11, 0.2 MICRON FILTER
- VL SL00-0
- VL SL00-X0
- VL SL00-XP
- VL SP 22-00, 2 SPIKES
- VL ST02-0
- VL ST10-0
- VL TR 00-0 TRANSFUSION
- VOLUMAT LINE
- VOLUMAT LINE INFUSION SET WITH BURETTE
- VOLUMAT LINE PVC-FREE SET
- VOLUMAT LINE PVC-FREE SET WITH 0.2 MICRON FILTER
- VOLUMAT LINE VL SP40-11, PUR MATERIAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.