Medical device licence · 71468 · Class 3
ABL80 FLEX SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 29, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71468
- Licence holder
- Radiometer Medical ApsBronshoj, Denmark
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 29, 2006
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABL80 FLEX SYSTEM - ANALYZER
- ABL80 FLEX SYSTEM - BLOOD GAS/HCT, NO QC
- ABL80 FLEX SYSTEM - BLOOD GAS/HCT, QC
- ABL80 FLEX SYSTEM - FULL ASSAY CASSETTE, NO GLUCOSE, NO QC
- ABL80 FLEX SYSTEM - FULL ASSAY CASSETTE, NO QC
- ABL80 FLEX SYSTEM - FULL ASSAY CASSETTE, QC
- ABL80 FLEX SYSTEM - FULL ASSAY CASSETTE, QC, NO GLUCOSE
- ABL80 FLEX SYSTEM - SP80 - SOLUTION PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.