Medical device licence · 114028 · Class 3
EXENT ANALYSER
Yes: licensed in Canada
Licence status Issued (active); first licensed September 25, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114028
- Licence holder
- The Binding Site Group LimitedBirmingham, United Kingdom
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 25, 2025
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXENT ANALYSER
- EXENT DILUENT 1
- EXENT DISPOSABLE MALDI PLATE PACK
- EXENT ELUTION BUFFER 1
- EXENT HCCA MALDI MATRIX PACK
- EXENT IMMUNOGLOBULIN ISOTYPES (GAM) CONTROL PACK
- EXENT MASS CALIBRATION STANDARD 1
- EXENT WASH SOLUTION 1
- IMMUNOGLOBULIN ISOTYPES (GAM) FOR THE EXENT ANALYSER
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 “exent”. A notice may cover another product or only some lots: read it to see what it covers.
- EXENT® AnalyserApril 29, 2026 · Chemistry · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.