BEUDAMED
    FDA Registration Active 🇨🇱 Chile

    Medical Glove

    Reg #: 3027977504 · FEI: 3027977504 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDLINE CHILE SPA
    Registration Number
    3027977504
    FEI Number
    3027977504
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ave. Boulevard Poniente 1313 Bodenor Flexcenter
    City
    Pudahuel Region Metropolitana
    Country
    CL

    Regulatory Submissions

    510(k) Number
    K151750

    Owner / Operator

    Firm Name
    Medline Chile SPA
    Operator Number
    10088604
    Address
    Ave. Boulevard Poniente 1313 Bodenor Flexcenter
    City
    Pudahuel
    State
    CL-NOTA
    Postal Code
    9031287
    Country
    CL
    Correspondent
    Gao Xing Yu

    US Agent

    Business Name
    Simcon International LLC
    Contact Name
    Rosanna Lee
    Address
    1200 Townline Rd
    City
    Mundelein
    State
    IL
    ZIP
    60060
    Country
    US
    Email
    [email protected]
    Phone
    847 9492290

    Products

    Device Name Product Code
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA

    Proprietary Names

    Medical Glove

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device