Medical device licence · 87764 · Class 2
INDIKO SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 2, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 87764
- Licence holder
- Thermo Fisher Scientific Inc.Beverly, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 2, 2011
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INDIKO SYSTEM - GLUCOSE (HK) (ASSAY)
- INDIKO WITH ISE UNIT
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 “indiko”. A notice may cover another product or only some lots: read it to see what it covers.
- Indiko System and Indiko Plus (2013-12-13)November 25, 2016 · Medical devices · Medical devices · Type III
- Indiko and Indiko Plus (2014-02-28)February 16, 2015 · 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.