BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    Assura Irrigation Pressplate

    Reg #: 3003814961 · FEI: 3003814961 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLOPLAST HUNGARY KFT
    Registration Number
    3003814961
    FEI Number
    3003814961
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BUZAVIRAG UT 15
    City
    TATABANYA Komarom-Esztergom
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K121833

    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
    Jason Woehrle
    Address
    1601 West River Road N
    City
    Minneapolis
    State
    MN
    ZIP
    55411
    Country
    US
    Email
    [email protected]
    Phone
    612 7302063

    Products

    Device Name Product Code
    Irrigator, Ostomy EXD

    Proprietary Names

    Assura Irrigation Pressplate Assura Ostomy Bag Coloplast Irrigation Colotip SenSura Mio Hospital Irrigation Set Assura Irrigation Set SenSura Mio Irrigation Sleeve Coloplast Irrigation Set Kit Sensura Mio Irrigation Sleeves

    Establishment Types

    Manufacture Medical Device