Medical device licence · 107557 · Class 3
VANADIS EXTRACT, CORE, VIEW
Yes: licensed in Canada
Licence status Issued (active); first licensed April 5, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107557
- Licence holder
- Wallac OyTurku, Finland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 5, 2022
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VANADIS CORE BUFFER KIT
- VANADIS CORE CELL FREE DNA ANALYSIS UNIT
- VANADIS EXTRACT BIND AND WASH KIT
- VANADIS EXTRACT CELL FREE DNA EXTRACTION UNIT
- VANADIS EXTRACT REAGENT KIT
- VANADIS VIEW MOLECULE COUNTING UNIT AND SYSTEM SOFTWARE
- VANADIS VIEW PLATE
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 “vanadis”. A notice may cover another product or only some lots: read it to see what it covers.
- Vanadis Core T21/T18/T13 Reagent CartridgeAugust 18, 2023 · Chemistry · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.