Medical device licence · 3738 · Class 3
RAPIDLAB 348EX SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 2, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 3738
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 2, 1999
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 348 SYSTEM - CA++ SENSOR
- 348 SYSTEM - CL- SENSOR
- 348 SYSTEM - GAS CARTRIDGE PACK
- 348 SYSTEM - HCT SENSOR
- 348 SYSTEM - INSTRUMENT
- 348 SYSTEM - K+ SENSOR
- 348 SYSTEM - NA+ SENSOR
- 348 SYSTEM - PCO2 SENSOR
- 348 SYSTEM - PH SENSOR
- 348 SYSTEM - PO2 SENSOR
- 348 SYSTEM - REAGENTS
- 348 SYSTEM - REFERENCE ELECTRODE
- 348 SYSTEM - REFERENCE SENSOR REFILL
- 348 SYSTEM - TEST/BLANK SENSORS
- RAPIDLAB 348EX SYSTEM
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 “rapidlab”. A notice may cover another product or only some lots: read it to see what it covers.
- RAPIDLab® 348EX SystemJuly 2, 2026 · Chemistry · Performance · Type II
- RAPIDPoint 405, 500 and RAPIDLab 1245 Blood Gas Analyzer (2018-07-24)August 17, 2018 · Medical devices · Medical devices · Type II
- RAPIDlab 1265 System - Analyzer (2015-05-06)June 1, 2015 · Medical devices · Health products · Type III
- Rapidpoint 405, Rapidlab 1265 System Analyzers and Rapidpoint 500 System - Main Unit (2015-01-07)January 21, 2015 · Medical devices · Health products · Type III
- Rapidpoint and Rapidlab Systems (2013-09-24)October 31, 2013 · 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.