BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Clarius OB AI

    Reg #: 3012747207 · FEI: 3012747207 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CLARIUS MOBILE HEALTH CORP.
    Registration Number
    3012747207
    FEI Number
    3012747207
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    205-2980 Virtual Way
    City
    Vancouver British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K233955

    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
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Clarius OB AI

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device