BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Assura Irrigation Pressplate

    Reg #: 3030087693 · FEI: 3030087693 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Coloplast Manufacturing US, LLC.
    Registration Number
    3030087693
    FEI Number
    3030087693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4008 Heritage Drive
    City
    Brookshire
    State
    TX
    ZIP
    77423
    Country
    US

    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

    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

    Repack or Relabel Medical Device