ApprovalTrail

Medical device licence · 63836 · Class 3

RAPIDLAB 1245 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
63836
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
9

Devices on this licence

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

  • RAPIDLAB 1245 SYSTEM - ANALYZER
  • RAPIDLAB 1245 SYSTEM - CONTROL CARTRIDGE
  • RAPIDLAB 1245 SYSTEM - PC02
  • RAPIDLAB 1245 SYSTEM - PH SENSOR
  • RAPIDLAB 1245 SYSTEM - PO2 SENSOR
  • RAPIDLAB 1245 SYSTEM - REAGENT CARTRIDGES
  • RAPIDLAB 1245 SYSTEM - REFERENCE SENSOR REFILL KIT
  • RAPIDLAB 1245 SYSTEM - WASH CARTRIDGE
  • 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.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.