Medical device licence · 102606 · Class 2
EVIDENCE MULTISTAT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 20, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102606
- Licence holder
- Randox Laboratories Ltd.Crumlin, AT, United Kingdom
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- March 20, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EVIDENCE MULTISTAT
- EVIDENCE MULTISTAT - DRUGS OF ABUSE ARRAY I URINE (DOA I URN)
- EVIDENCE MULTISTAT DRUGS OF ABUSE ARRAY BLOOD (CE) (DOA BLOOD (CE))
- RANDOX EVIDENCE MULTISTAT DOA TOXPLEX URINE
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 “evidence”. A notice may cover another product or only some lots: read it to see what it covers.
- Evidence MultiSTAT (2019-11-20)January 6, 2020 · Medical devices · Medical devices · Type III
- Evidence MultiSTAT (2019-06-28)January 6, 2020 · Medical devices · Medical devices · Type III
- Evidence Investigator Analyzer (2018-11-10)April 12, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.