BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    UNOMEDICAL A/S

    Reg #: 8021545 · FEI: 1000477110 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    28
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    UNOMEDICAL A/S
    Registration Number
    8021545
    FEI Number
    1000477110
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Aaholmvej 1 - 3
    City
    OSTED, LEJRE Sjalland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K162812

    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
    Jared Ragone

    US Agent

    Business Name
    ConvaTec
    Contact Name
    Courtney Smith
    Address
    20 Maguire
    City
    Lexington
    State
    MA
    ZIP
    02420
    Country
    US
    Email
    [email protected]
    Phone
    603 2470255

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Introducer, Syringe Needle KZH

    Proprietary Names

    Silhouette® Paradigm® MiniMed™ Silhouette™ Infusion set Silhouette® (Luer Lock) VariSoft™ Accu-Chek TenderLink™ Comfort™ Accu-Chek Tender™ Comfort Short™ Autosoft XC AutoSoft90™ MiniMed™ Mio™ Advance iLet Flex Medtronic Extended infusion set contact detach TruSteel™ neria™ guard MiniMed™ Mio™ Infusion set Sure-T® Paradigm® MiniMed™ Quick set™ Infusion set Quick-set® Paradigm® MiniMed™ Sure T™ Infusion set Mio® Neria Soft 90 YpsoPump Inset DANA inset II MiniMed™ Mio™ 30 Infusion Set MiniMed™ Mio™ 30 AutoSoft30™

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device