BEUDAMED
    FDA Registration Active 🇫🇷 France

    ReTrace Ureteral Access Sheath

    Reg #: 9610711 · FEI: 3002807917 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLOPLAST MANUFACTURING FRANCE, SAS
    Registration Number
    9610711
    FEI Number
    3002807917
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Avenue Edmond Rostand, CS 70218
    City
    Sarlat la Caneda Cedex Dordogne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K181811

    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
    Endoscopic Access Overtube, Gastroenterology-Urology FED

    Proprietary Names

    ReTrace Ureteral Access Sheath

    Establishment Types

    Manufacture Medical Device