BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Medtronic Extended infusion set

    Reg #: 8021545 · FEI: 1000477110 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    UNOMEDICAL A/S
    Registration Number
    8021545
    FEI Number
    1000477110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Aaholmvej 1 - 3
    City
    OSTED, LEJRE Sjalland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K210544

    Owner / Operator

    Firm Name
    Convatec, Inc.
    Operator Number
    8021535
    Address
    7815 National Service Road, Suite 600
    City
    Greensboro
    State
    NC
    Postal Code
    27409
    Country
    US
    Correspondent
    Courtney Smith

    US Agent

    Business Name
    ConvaTec Inc.
    Contact Name
    Courtney Smith
    Address
    7815 National Service Road, Suite 600
    City
    Greensboro
    State
    NC
    ZIP
    27409
    Country
    US
    Email
    [email protected]
    Phone
    239 7762947

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    Medtronic Extended infusion set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device