BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ultratellege USA Co. LTD.

    Reg #: 3009543101 · FEI: 3009543101 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    Ultratellege USA Co. LTD.
    Registration Number
    3009543101
    FEI Number
    3009543101
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2111 Peninsula Drive
    City
    Erie
    State
    PA
    ZIP
    16506
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160198

    Owner / Operator

    Firm Name
    Ultratellege USA Co. Ltd
    Operator Number
    10040377
    Address
    2111 Peninsula Drive
    City
    Erie
    State
    PA
    Postal Code
    16506
    Country
    US
    Correspondent
    Tao Song

    Products

    Device Name Product Code
    Lithotriptor, Electro-Hydraulic FFK

    Proprietary Names

    UreTron Multi Probe Lithotripter System UreTron Flexible Probe UreTron

    Establishment Types

    Manufacture Medical Device