BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    KIDNEY ASSIST-transport

    Reg #: 3008388260 · FEI: 3008388260 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    UNITRON GROUP BV
    Registration Number
    3008388260
    FEI Number
    3008388260
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Schansestraat 7
    City
    IJzendijke Zeeland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K211333

    Owner / Operator

    Firm Name
    Unitron Group BV
    Operator Number
    10032425
    Address
    Schansestraat 7
    City
    IJzendijke
    State
    Zeeland
    Postal Code
    4515 RN
    Country
    NL
    Correspondent
    Manon de Koeijer

    US Agent

    Business Name
    Qserve Group US Inc
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    System, Perfusion, Kidney KDN

    Proprietary Names

    KIDNEY ASSIST-transport

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)