Medical device licence · 12968 · Class 2
EIGHTCHECK X-TRA CAP PIERCABLE
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed October 8, 1999; ended October 31, 1999. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 12968
- Licence holder
- Sysmex America, Inc.Lincolnshire, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- October 8, 1999
- Ended
- October 31, 1999
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EIGHTCHECK X-TRA CAP PIERCABLE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “eightcheck”. A notice may cover another product or only some lots: read it to see what it covers.
- Sysmex E-Check, EIGHTCHECK 3WP XTRA, SYSMEX SCS-1000, XN CHECK, XN CAL, XN CAL PF, XN CAL - CUSTOMER SET, XN CAL PF - CUSTOMER SET, XN-L CHECK (2018-05-08)May 25, 2018 · Medical devices · Medical devices · Type III
- Eightcheck 3WP X-TRA Control (2013-05-13)February 11, 2014 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.