BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Restorelle Y

    Reg #: 2125050 · FEI: 2125050 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLOPLAST MANUFACTURING US, LLC
    Registration Number
    2125050
    FEI Number
    2125050
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1601 W River Rd N
    City
    MINNEAPOLIS
    State
    MN
    ZIP
    55411
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112322

    Owner / Operator

    Firm Name
    Coloplast Corp.
    Operator Number
    8010144
    Address
    1601 West River Road North
    City
    Minneapolis
    State
    MN
    Postal Code
    55411
    Country
    US

    Products

    Device Name Product Code
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO

    Proprietary Names

    Restorelle Y

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility