BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF22

    Reg #: 3011162972 · FEI: 3011162972 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    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
    K160674

    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
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF22 ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF48 ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER, UHF70

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)