BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    MiniMed™ Quick set™ Infusion set

    Reg #: 3003442380 · FEI: 3003442380 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Unomedical Devices S.A de C.V
    Registration Number
    3003442380
    FEI Number
    3003442380
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Avenida Fomento Industrial Lote 9 Manzana 3, Parque Industrial Del Norte
    City
    Reynosa Tamaulipas
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K160648

    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
    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

    MiniMed™ Quick set™ Infusion set MiniMed™ Sure T™ Infusion set Mio® Quick-set® Paradigm® MiniMed™ Mio™ Infusion set Sure-T® Paradigm®

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)