Medical device licence · 80600 · Class 3
ABL80 FLEX CO-OX
Yes: licensed in Canada
Licence status Issued (active); first licensed September 3, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80600
- Licence holder
- Radiometer Medical ApsBronshoj, Denmark
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 3, 2009
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABL80 FLEX CO-OX - CAPILLARY SAMPLING ADAPTERS
- ABL80 FLEX CO-OX - FLUIDICS KIT
- ABL80 FLEX CO-OX - SP80 CO-OX (SOLUTION PACK)
- ABL80 SC80 FLEX CO-OX - BG, NO QC3
- ABL80 SC80 FLEX CO-OX - BG, QC3
- ABL80 SC80 FLEX CO-OX - FULL - NO GLU, NO QC3
- ABL80 SC80 FLEX CO-OX - FULL - NO GLU, QC3
- ABL80 SC80 FLEX CO-OX - FULL, NO QC3
- ABL80 SC80 FLEX CO-OX - FULL, QC3
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.