BEUDAMED
    FDA Registration Active 🇨🇳 China

    EnSite™ X EP System Amplifier Cart

    Reg #: 3012619193 · FEI: 3012619193 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Dongguan Ergotron Precision Technology Co., LTD
    Registration Number
    3012619193
    FEI Number
    3012619193
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    The 3rd Industry Section, Juzhou, Shijie Town of Dongguan City, Guangdong, PRC
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242016

    Owner / Operator

    Firm Name
    Ergotron Inc.
    Operator Number
    10090835
    Address
    1181 Trapp Rd
    City
    Eagan
    State
    MN
    Postal Code
    55121
    Country
    US

    US Agent

    Business Name
    Ergotron Inc.
    Contact Name
    John Berger
    Address
    1181 Trapp Rd
    City
    Eagan
    State
    MN
    ZIP
    55121
    Country
    US
    Email
    [email protected]
    Phone
    651 2374342

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    EnSite™ X EP System Amplifier Cart

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)