Medical device licence · 79813 · Class 3
AK-96 DIALYSIS MACHINE
Yes: licensed in Canada
Licence status Issued (active); first licensed May 28, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79813
- Licence holder
- Gambro Lundia AbLund, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- Single Device
- First licensed
- May 28, 2009
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AK 96, ADVANCE
- AK 96, BASIC
- AK 96, EFFICIENT
- AK 96, EFFICIENT BPM
- IN-CENTER AK-96 DIALYSIS MACHINE
- SELF-CARE AK-96 DIALYSIS MACHINE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.