Medical device licence · 99298 · Class 2
XPAND NT SINGLE-USE IRIS EXPANSION SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed June 12, 2017; ended November 26, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 99298
- Licence holder
- Diamatrix Ltd.The Woodlands, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- June 12, 2017
- Ended
- November 26, 2018
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- XPAND NT SINGLE-USE IRIS EXPANSION SYSTEM
- XPAND NT X1 READY-LOADED IRIS SPECULUM
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 “xpand”. A notice may cover another product or only some lots: read it to see what it covers.
- Dimension Vista System, Dimension Xpand System & Dimension Exl System - Total Bilirubin Assay (2020-02-21)April 24, 2020 · Medical devices · Medical devices · Type III
- DIMENSION CLINICAL CHEMISTRY, DIMENSION XPAND, DIMENSION EXL SYSTEMS (2019-07-19)August 2, 2019 · Medical devices · Medical devices · Type III
- Dimension Xpand System - Xpand Plus, Dimension EXL Analyzer with LM, Dimension EXL 200 Analyzer, Dimension Xpand System - Xpand Plus with HM Analyzer, Dimension RXL Max W/HM Analyzer (2019-04-07)May 3, 2019 · Medical devices · Medical devices · Type III
- Dimension Xpand System - Xpand Plus Basic Analyzer (Class 2 and 3), Xpand Plus with HM Analyzer (Class 2 and 3) and Dimension EXL 200 Analyzer (2018-01-16)February 1, 2018 · 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.