BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Exact EV5C Transducer

    Reg #: 3011162972 · FEI: 3011162972 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SONELE INC.
    Registration Number
    3011162972
    FEI Number
    3011162972
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    46 Riviera Drive
    City
    Markham Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K192303

    Owner / Operator

    Firm Name
    SONELE Inc.
    Operator Number
    10051244
    Address
    46 Riviera Drive
    City
    Markham
    State
    Ontario
    Postal Code
    L3R 5M1
    Country
    CA
    Correspondent
    Eric Reider

    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
    Biopsy Needle Guide Kit OIJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    Exact EV5C Transducer ExactVu™ High Resolution Micro-Ultrasound System Transrectal Reusable Needle Guide for EV29L transducer for 16 GA Needle Transrectal Reusable Needle Guide for EV29L transducer - 18GA Exact EV9C Transducer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)