Medical device licence · 81649 · Class 3
REACTION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 7, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 81649
- Licence holder
- Viora, Ltd.Migdal Haemek, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group
- First licensed
- January 7, 2010
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REACTION
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 “reaction”. A notice may cover another product or only some lots: read it to see what it covers.
- Access 2 Reaction VesselsNovember 13, 2025 · General hospital and personal use · Performance · Type II
- Atellica CH Reaction Ring Cuvette SegmentNovember 4, 2024 · Ophthalmology · Performance · Type II
- Atellica CH Reaction Cuvette Segment (2020-02-17)February 20, 2020 · Medical devices · Medical devices · Type II
- Dimension Vista LOCI Reaction Vessels (2018-07-17)August 17, 2018 · Medical devices · Medical devices · Type III
- 5mL Reaction Vessels used with the m2000sp Instrument (2014-07-09)August 8, 2014 · Medical devices · Medical devices · Type III
- Cobas Polymerised Chain Reaction (PCR) Urine Kit (2013-12-06)March 18, 2014 · Medical devices · Medical devices · Type III
- Dimension Reaction Vessels (2013-12-19)January 24, 2014 · Medical devices · Medical devices · Type III
- Access Reaction Vessels (2013-09-30)November 25, 2013 · 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.