Medical device licence · 99923 · Class 3
PRO-MCOMPLETE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 30, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99923
- Licence holder
- Pro-Lab DiagnosticsRichmond Hill, ON, Canada
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 30, 2017
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PRO-MCOMPLETE
- PRO-MCOMPLETE EXTERNAL POSITIVE CONTROL
- PRO-MCOMPLETE EXTRACTION BUFFER
- PRO-MCOMPLETE TEST CASSETTE
- STERILE SWAB
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.