Medical device licence · 105645 · Class 2
VITEK DENSICHEK
Yes: licensed in Canada
Licence status Issued (active); first licensed December 18, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105645
- Licence holder
- Biomerieux SaRockland, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 18, 2020
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VITEK DENSICHEK DISPLAY BASE
- VITEK DENSICHEK MCFARLAND REFERENCE KIT
- VITEK DENSICHEK POD
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 “vitek”. A notice may cover another product or only some lots: read it to see what it covers.
- VITEK® 2 SystemsJanuary 21, 2026 · Microbiology · Performance · Type II
- Vitek 2 Software Version 9.01/9.02July 12, 2024 · Microbiology · Performance · Type II
- Vitek 2 System - Susceptibility Test CardsApril 2, 2024 · Microbiology · Performance · Type II
- Vitek® 2 Ast-N391August 2, 2022 · Medical devices · Labelling and packaging · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.