BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Flexible Implant Tube

    Reg #: 9611894 · FEI: 3002807741 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NUCLETRON B.V.
    Registration Number
    9611894
    FEI Number
    3002807741
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3900 AX VEENENDAAL, P.O. BOX 930, Waardgelder 1
    City
    VEENENDAAL Utrecht
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K032372

    Owner / Operator

    Firm Name
    Nucletron B.V.
    Operator Number
    8030474
    Address
    3900 Ax Veenendaal, P.O. Box 930, Waardgelder 1
    City
    Veenendaal
    State
    Utrecht
    Postal Code
    3905 TH
    Country
    NL

    US Agent

    Business Name
    Elekta
    Contact Name
    Thomas Valentine
    Address
    400 Perimeter Center Terrace, Suite 50
    City
    ATL
    State
    GA
    ZIP
    30346
    Country
    US
    Email
    [email protected]
    Phone
    404 7972537

    Products

    Device Name Product Code
    System, Applicator, Radionuclide, Remote-Controlled JAQ

    Proprietary Names

    Flexible Implant Tube OncoSmart Flange Molding Set CT/MR OncoSmart Catheter Sets OncoSmart Catheter System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device