BEUDAMED
    FDA Registration Active 🇫🇷 France

    Silicone Prostatectomy Catheter

    Reg #: 3012649202 · FEI: 3012649202 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Centre de distribution Coloplast Le Plessis Pate
    Registration Number
    3012649202
    FEI Number
    3012649202
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2 Rue Jacqueline Auriol
    City
    Le Plessis-Pate Essonne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K013172

    Owner / Operator

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

    US Agent

    Business Name
    COLOPLAST CORP
    Contact Name
    Brian Schmidt
    Address
    1601 West River Road N
    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

    Silicone Prostatectomy Catheter

    Establishment Types

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