Medical device licence · 95198 · Class 2
PENTRA XLR
Yes: licensed in Canada
Licence status Issued (active); first licensed May 20, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95198
- Licence holder
- Horiba Abx SasMontpellier, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 20, 2015
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABX BASOLYSE II
- ABX EOSINOFIX
- ABX LYSEBIO
- PENTRA XLR
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 “pentra”. A notice may cover another product or only some lots: read it to see what it covers.
- ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM (2016-02-19)May 31, 2016 · Medical devices · Medical devices · Type II
- ABX Pentra 400 (2016-01-18)February 12, 2016 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.