Medical device licence · 60678 · Class 2
BETATEX DIRECT PLUS
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed October 4, 2002; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60678
- Licence holder
- Omega Diagnostics Group PlcAlva, SL, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 4, 2002
- Ended
- February 16, 2004
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BETATEX DIRECT PLUS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.