BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Ir-192 source

    Reg #: 9611894 · FEI: 3002807741 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    53
    Establishment Types
    1
    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
    K953946

    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

    Ir-192 source CT/MR Applicator Clamp Vaginal Applicator Set Fritz Adjustable Intralumenal Applicator Set Trocar needles Norman Simon Applicator Set Template Set, Breast Implants (complete) Basic Rotte Endometrial Applicator Set Shielded Cylindrical Applicator Set Interstitial Needle Basic Set Ring Applicator Set Oesophageal Applicator Set Fritz Adjustable Intralumenal Appl. Set Rowland Oesophageal Applicator Set Bonvoisin-Gerard Applicator Set Leipzig Applicator Set Catheter Insertion Set, 6F Trocar Houdek Applicator Set Basic Norman Simon Applicator Set MUPIT Applicator Set NAG Brachyflex Set Catheter Deflection Set Fritz Adjustable Intralumenal Applicator Horiot Endometrial Applicator Set Interstitial Needle Set Rotte Endometrial Applicator Set Selectron Standard Shielded Applicator Set Bevel needles Standard Shielded Applicator Set Surface Mould Applicator Set Rotte Applicator Set Flexiguide Needle Set Pipard Tounge Template Set Demanes Rodriquez Applicator Set Arnhem Bile Duct Applicator Nasopharyngeal Applicator Set Catheter Insertion Set, 6F Bevel Selectron Standard Applicator Set Henschke Applicator Set Porter Perineal Applicator Set Miami Vaginal Applicator Set Standard Nasopharyngeal Applicator Set Novi Sad Inflatable Rectal Applicator Set Flexible Implant Tube Set Brain Needle Set with Fixing Tool Pancreatic Flexible Needle Set Speiser Needle Insertion System Bladder Applicator Set Martinez Endometrial Applicator Set Pencil point needles Brain, Flexible Implant Needle Set Lumencath Applicator Set Super Mould Applicator Set

    Establishment Types

    Manufacture Medical Device