ApprovalTrail

Medical device licence · 60369 · Class 3

STAT PROFILE CCX 1 SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed August 27, 2002; ended November 21, 2023. It is in Health Canada’s archive of licences no longer in force.
Licence number
60369
Licence holder
Nova Biomedical CorporationWaltham, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 27, 2002
Ended
November 21, 2023
Devices covered
23

Devices on this licence

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

  • STAT PROFILE CCX 1 ANALYZER
  • STAT PROFILE CCX 1 SYSTEM - AUTO CARTRIDGE QC ABG
  • STAT PROFILE CCX 1 SYSTEM - AUTO CARTRIDGE QC CHEM
  • STAT PROFILE CCX 1 SYSTEM - BLANK SENSORS
  • STAT PROFILE CCX 1 SYSTEM - BUN MEMBRANE KIT/SENSOR
  • STAT PROFILE CCX 1 SYSTEM - CALCIUM SENSOR
  • STAT PROFILE CCX 1 SYSTEM - CHLORIDE SENSOR
  • STAT PROFILE CCX 1 SYSTEM - CONTROL MULTIPACK
  • STAT PROFILE CCX 1 SYSTEM - CREATININE MEMBRANE KIT/SENSOR
  • STAT PROFILE CCX 1 SYSTEM - GLUCOSE MEMBRANE KIT/SENSOR
  • STAT PROFILE CCX 1 SYSTEM - LACTATE MEMBRANE KIT/SENSOR
  • STAT PROFILE CCX 1 SYSTEM - LINEARITY SOLUTION SETS
  • STAT PROFILE CCX 1 SYSTEM - MAGNESIUM SENSOR
  • STAT PROFILE CCX 1 SYSTEM - PCO2 MEMBRANE KIT/SENSOR
  • STAT PROFILE CCX 1 SYSTEM - PH SENSOR
  • STAT PROFILE CCX 1 SYSTEM - PO2 MEMBRANE KIT/SENSOR
  • STAT PROFILE CCX 1 SYSTEM - POTASSIUM SENSOR
  • STAT PROFILE CCX 1 SYSTEM - PROBE AND CLEANING KIT
  • STAT PROFILE CCX 1 SYSTEM - REAGENT CARTRIDGE
  • STAT PROFILE CCX 1 SYSTEM - REFERENCE ELECTRODE
  • STAT PROFILE CCX 1 SYSTEM - SENSOR MODULE
  • STAT PROFILE CCX 1 SYSTEM - SO2 SENSOR AND CALIBRATORS
  • STAT PROFILE CCX 1 SYSTEM - SODIUM SENSOR

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