BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    CHANGE HEALTHCARE CANADA COMPANY

    Reg #: 8022257 · FEI: 3003757840 · Expires 2026
    View on FDA
    Products
    30
    Proprietary Names
    30
    Establishment Types
    3
    Classifications
    30

    Registration Details

    Registration Name
    CHANGE HEALTHCARE CANADA COMPANY
    Registration Number
    8022257
    FEI Number
    3003757840
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10711 CAMBIE ROAD
    City
    RICHMOND British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K874514

    Owner / Operator

    Firm Name
    Change Healthcare Canada Company
    Operator Number
    8022257
    Address
    10711 CAMBIE ROAD
    City
    RICHMOND
    State
    British Columbia
    Postal Code
    V6X 3G5
    Country
    CA
    Correspondent
    Alona Golik

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Blood Pressure Cuff DXQ
    System, Image Processing, Radiological LLZ
    Oximeter DQA
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Automated Radiological Image Processing Software QIH
    Computer, Diagnostic, Programmable DQK
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Index-Generating Electroencephalograph Software OLW
    Burst Suppression Detection Software For Electroencephalograph ORT
    Monitor, Breathing Frequency BZQ
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Oximeter, Ear DPZ
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Cannula, Nasal, Oxygen CAT
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Reduced- Montage Standard Electroencephalograph OMC
    Electrode, Cutaneous GXY
    Full-Montage Standard Electroencephalograph GWQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Electrode, Electrocardiograph DRX
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    Stethoscope, Esophageal, With Electrical Conductors BZT

    Proprietary Names

    Orthoview 7.2 McKesson Radiology Mammography Plus Change Healthcare Mammography Plus Change Healthcare Anatomical AI Change Healthcare Cardiology Change Healthcare Cardiology Hemodynamics McKesson Cardiology TOMTEC-ARENA Change Healthcare Enterprise Viewer Change Healthcare Stratus Imaging Viewer McKesson Radiology Change Healthcare Radiology Solutions McKesson Cardiology ECG Management Change Healthcare Cardiology ECG Management ISA CO2 Conserus Enterprise Viewer Change Healthcare Stratus Imaging PACS ECG Electrodes Ambu BlueSensor Corridor4DM Skin Temperature Probe, Small Skin Temperature Probe, Large General Purpose Rectal/Esophageal Probe, Medium Skin Temperature Probe, Medium General Purpose Rectal/Esophageal Probe, Large Oasis Stratus Imaging Diagnostic Viewer McKesson Cardiology Hemo Change Healthcare Cardiology Hemo XD3

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Repack or Relabel Medical Device