BEUDAMED
    FDA Registration Active 🇨🇳 China

    CURA 16

    Reg #: 3014781443 · FEI: 3014781443 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MinFound Medical Systems Co., Ltd.
    Registration Number
    3014781443
    FEI Number
    3014781443
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.851, Yinhai Road, Xiasha Street, Qiantang District, Hangzhou City, 310018 Zhejiang, P.R. China
    City
    HANGZHOU Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K173076

    Owner / Operator

    Firm Name
    MinFound Medical Systems, Ltd.
    Operator Number
    10059426
    Address
    No.851, Yinhai Road, Xiasha Street, Qiantang District, Hangzhou City, 310018 Zhejiang, P.R. China
    City
    HANGZHOU
    State
    Zhejiang
    Postal Code
    310018
    Country
    CN
    Correspondent
    Tracy Wang

    US Agent

    Business Name
    FMI Medical Systems, Inc.
    Contact Name
    FMI FMI
    Address
    29001 Solon Road, Unit A
    City
    Solon
    State
    OH
    ZIP
    44139
    Country
    US
    Email
    [email protected]
    Phone
    440 6005952

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    CURA 16 ScintCare CT 16

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)