BEUDAMED
    FDA Registration Active 🇨🇳 China

    Andorate

    Reg #: 3008058134 · FEI: 3008058134 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SMARTDATA SUZHOU CO., LTD
    Registration Number
    3008058134
    FEI Number
    3008058134
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    F4, Building 7, 198 Jinshan Rd
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230932

    Owner / Operator

    Firm Name
    Smartdata Suzhou Co., Ltd.
    Operator Number
    10030656
    Address
    F4, Building 7, 198 Jinshan Rd
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215011
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Endoscope Channel Accessory ODC
    Endoscopic Irrigation/Suction System OCX

    Proprietary Names

    Andorate

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)