BEUDAMED
    FDA Registration Active 🇹🇳 Tunisia

    Folysil Silicone Catheter

    Reg #: 3029906222 · FEI: 3029906222 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ADHE-ELS INTERNATIONAL
    Registration Number
    3029906222
    FEI Number
    3029906222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Km 128, Z.I., BP 84
    City
    Kalaa Kebira Sousse
    Country
    TN

    Regulatory Submissions

    510(k) Number
    K013174

    Owner / Operator

    Firm Name
    Adhe-Els International
    Operator Number
    10088762
    Address
    Km 128, Z.I., BP 84
    City
    Kalaa Kebira
    State
    Sousse
    Postal Code
    4060
    Country
    TN
    Correspondent
    Mariem Gaaloul

    US Agent

    Business Name
    Coloplast
    Contact Name
    Brian Schmidt
    Address
    1601 West River Road
    City
    Minneapolis
    State
    MN
    ZIP
    55411
    Country
    US
    Email
    [email protected]
    Phone
    612 8651177

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Folysil Silicone Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)