BEUDAMED
    FDA Registration Active 🇨🇳 China

    MDNC-2221

    Reg #: 3007809729 · FEI: 3007809729 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CORETRONIC PROJECTION (KUNSHAN) CORPORATION
    Registration Number
    3007809729
    FEI Number
    3007809729
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 20,3rd Ave, Kunshan Free Trade Zone
    City
    Kunshan Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K133663

    Owner / Operator

    Firm Name
    Coretronic Projection (kunshan) Corporation
    Operator Number
    10057805
    Address
    No. 20,3rd Ave, Kunshan Free Trade Zone
    City
    Kunshan
    State
    Jiangsu
    Postal Code
    215300
    Country
    CN
    Correspondent
    Cindy Li

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    MDNC-2221

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)