BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Two-Toned Bonded Gemini Sterilization Wrap

    Reg #: 3016073670 · FEI: 3016073670 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medline Logistics Japan G.K.
    Registration Number
    3016073670
    FEI Number
    3016073670
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    34-1 Toriisaki
    City
    Nishihocho, Aisai-shi Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K220365

    Owner / Operator

    Firm Name
    Medline Industries, LP
    Operator Number
    1417592
    Address
    Three Lakes Drive
    City
    Northfield
    State
    IL
    Postal Code
    60093
    Country
    US
    Correspondent
    Stephanie Augsburg

    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
    Wrap, Sterilization FRG

    Proprietary Names

    Two-Toned Bonded Gemini Sterilization Wrap Gemini Sterilization Wrap

    Establishment Types

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