Medical device licence · 63838 · Class 3

RAPIDLAB 1265 SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed February 20, 2004. It is in Health Canada’s list of active licences.

Licence number: 63838
Licence holder: Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class: Class III (moderate to high risk)
Licence type: System
First licensed: February 20, 2004
Devices covered: 15

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

RAPIDLAB 1200 SYSTEM- CA++ CALCIUM SENSOR
RAPIDLAB 1265 SYSTEM - ANALYZER
RAPIDLAB 1265 SYSTEM - CI SENSORS
RAPIDLAB 1265 SYSTEM - CONTROL CARTRIDGES
RAPIDLAB 1265 SYSTEM - GLUCOSE SENSORS
RAPIDLAB 1265 SYSTEM - K+ SENSOR
RAPIDLAB 1265 SYSTEM - LACTATE SENSORS
RAPIDLAB 1265 SYSTEM - NA SENSORS
RAPIDLAB 1265 SYSTEM - PCO2 SENSORS
RAPIDLAB 1265 SYSTEM - PH SENSORS
RAPIDLAB 1265 SYSTEM - PO2 SENSORS
RAPIDLAB 1265 SYSTEM - REAGENTS CARTRIDGES
RAPIDLAB 1265 SYSTEM - SENSOR REFILL KIT
RAPIDLAB 1265 SYSTEM - WASH CARTRIDGES
REFERENCE SENSOR

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.