BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Velacur ONE

    Reg #: 3016253057 · FEI: 3016253057 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SONIC INCYTES MEDICAL CORP
    Registration Number
    3016253057
    FEI Number
    3016253057
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1788 West 5th Avenue, Suite #309
    City
    Vancouver British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K251728

    Owner / Operator

    Firm Name
    Sonic Incytes
    Operator Number
    10077443
    Address
    1788 West 5th Avenue, Suite #309
    City
    Vancouver
    State
    British Columbia
    Postal Code
    V6J 1P2
    Country
    CA
    Correspondent
    Tinuade Orimalade

    US Agent

    Business Name
    Z & B Enterprises, Inc.
    Contact Name
    RHONA SHANKER
    Address
    12154 Darnestown Road, #236
    City
    Darnestown
    State
    MD
    ZIP
    20878
    Country
    US
    Email
    [email protected]
    Phone
    240 5067963

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    Velacur ONE

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198