Medical device licence · 15123 · Class 2
MONOLYTH OXYGENATOR
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed December 7, 1999; ended October 31, 2000. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 15123
- Licence holder
- Sorin Biomedica Inc.Irvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- December 7, 1999
- Ended
- October 31, 2000
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MONOLYTH HOLDER
- MONOLYTH INTEGRATED MEMBRANE LUNG
- MONOLYTH M CAPILLARY MEMBRANE LUNG
- MONOLYTH PRO INTEGRATED MEMBRANE LUNG
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.