BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    Lexington International LLC

    Reg #: 3006368133 · FEI: 3006368133 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    GOOTEN INNOLIFE CORPORATION
    Registration Number
    3006368133
    FEI Number
    3006368133
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 12-1, Lane 267, Sec.3, Min Sheng Rd., Taya Dist.,
    City
    Taichung City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K093499

    Owner / Operator

    Firm Name
    Gooten Innolife Corporation
    Operator Number
    10024775
    Address
    No. 12-1, Lane 267, Sec.3, Min Sheng Rd., Taya Dist.
    City
    Taichung
    State
    TW-TXG
    Postal Code
    42844
    Country
    TW

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Laser, Comb, Hair OAP

    Proprietary Names

    Lexington International LLC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device