BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    CLARIUS MOBILE HEALTH CORP.

    Reg #: 3012747207 · FEI: 3012747207 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    65
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    CLARIUS MOBILE HEALTH CORP.
    Registration Number
    3012747207
    FEI Number
    3012747207
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    205-2980 Virtual Way
    City
    Vancouver British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K232704

    Owner / Operator

    Firm Name
    Clarius Mobile Health Corp.
    Operator Number
    10053451
    Address
    205-2980 Virtual Way
    City
    Vancouver
    State
    British Columbia
    Postal Code
    V5M 4X3
    Country
    CA
    Correspondent
    Laurent Pelissier

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Clarius Scanner PAL HD3 Clarius Ultrasound Scanner PAL HD3 Clarius Prostate AI Li-ion Battery Charger Clarius Ultrasound System Clarius Scanner C3 Clarius Scanner L7 Clarius C3 Ultrasound Scanner Clarius L7 Ultrasound Scanner Rechargeable Li-ion Battery Pack C3 HD3; C7 HD3; EC7 HD3; L7 HD3; L15 HD3; PA HD3; L20 HD3; Clarius Fan HD3; Clarius Power Fan HD3; Clarius Charger HD3 Viera Battery Charger Synergy Ultrasound Battery Basic MSK Ultrasound Curvilinear Scanner Synergy MSK Ultrasound Scanner Basic MSK Ultrasound Linear Scanner Synergy MSK Ultrasound Linear Scanner Synergy MSK Ultrasound Curvilinear Scanner Clarius Clip-on C3-L Clarius Scanner C7 Viera Portable Breast Ultrasound Linear Scanner Viera Rechargeable Li-ion Battery Synergy Ultrasound Single Charger Clarius Charger Clarius Battery Clarius MSK AI Clarius AI Clarius Bladder AI Clarius OB AI Clarius Ejection Fraction AI Clarius Median Nerve AI Synergy MSK Ultrasound Clarius L7 Premium Ultrasound Scanner Clarius C7 Premium Ultrasound Scanner Li-ion Battery Pack Synergy MSK Ultrasound Linear Scanner / Single Clarius Scanner EC7 Synergy MSK Ultrasound Linear Scanner / Non-Commercial Clarius C3 Premium Ultrasound Scanner Synergy MSK Ultrasound Curvilinear Scanner / Single Synergy MSK Ultrasound C7 Scanner / Non-Commercial Clarius EC7 Premium Ultrasound Scanner Viera™ Portable Breast Ultrasound Synergy MSK Ultrasound Battery Basic MSK Ultrasound C7 Scanner Synergy MSK Ultrasound Single Charger Clarius Fan Synergy MSK Ultrasound Curvilinear Scanner / Non-Commercial Clarius Dock Clarius EC7 Ultrasound Scanner Synergy MSK Ultrasound C7 Scanner Clarius C7 Ultrasound Scanner Clarius Cart Clarius Charger Hub Clarius Scanner EC7 HD Clarius Scanner L20 HD Clarius Scanner PA HD Clarius Charger HD Clarius Scanner C3 HD Clarius Battery HD Clarius Fan HD Clarius Scanner L15 HD Clarius Scanner C7 HD Clarius Scanner L7 HD

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)