BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    NUCLETRON B.V.

    Reg #: 9611894 · FEI: 3002807741 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    129
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    NUCLETRON B.V.
    Registration Number
    9611894
    FEI Number
    3002807741
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3900 AX VEENENDAAL, P.O. BOX 930, Waardgelder 1
    City
    VEENENDAAL Utrecht
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K161688

    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
    Neurological Stereotaxic Instrument HAW
    System, Therapeutic, X-Ray JAD
    System, X-Ray, Film Marking, Radiographic JAC
    System, Planning, Radiation Therapy Treatment MUJ

    Proprietary Names

    Advanced Gynecological Applicator Leksell Stereotactic System Vaginal CT/MR Multi Channel Applicator Set Catheter Set with Collar 6Fx293 mm Esteya Bonvoisin Gerard Esophageal Applicator Set Martinez Prostate Template set Cervix Ring Applicator set Smit Sleeve CT/MR Smit Sleeve Henschke Titanium Applicator Set Flexible Implant Tube CT/MR OncoSmart Catheter Sets OncoSmart Catheter System OncoSmart Flange Molding Set Valencia Ft Skin Applicator Set Valencia Skin Applicator Set Vienna Ring CT/MR Applicator Set Round Point Titanium Needle Set Trocar Point Titanium Needle Set Guiding Tube for Ring Set for Interstitial Ring MR Line Marker Utrecht Interstitial Fletcher CT/MR Applicator Set Interstitial Ring CT/MR Applicator set Utrecht Interstitial CT/MR Applicator set Guiding Tube for Ovoids Kuske Breast Applicator Set Breast CT/MR Template Set Kuske Breast Template Set CT Markers Set Oncentra External Beam Oncentra Masterplan Oncentra Masterplan Oncentra Brachy FREIBURG FLAP APPLICATOR SET ProGuide Needle OncoSelect Stepper Laptop Cart Oncentra Seeds ERCM - EndoCavity Rotational Mover Oncentra Prostate FLETCHER WILLIAMSON APPLICATOR SET Fletcher CT/MR Applicator Set XS RING CT/MR APPLICATOR SET STANDARD CT/MR APPLICATOR SET Fletcher CT/MR Applicator Set VAGINAL CT/MR APPLICATOR SET Vaginal Cylinder applicator Flexisource and Check Cable Bronchial Catheter Adapter Flexitron Transfer Tubes Cervix Rotterdam Applicators X-ray markers Ti vaginal Cylinder applicator set Source Position Check Ruler (SPCR) ROTTERDAM NASOPHARYNX MOULD SET INTRACAVITARY MOULD APPLICATOR SET Ft INTRACAVITARY MOULD APPLICATOR SET Leksell Vantage Stereotactic System Ir-192 source CT/MR Applicator Clamp Fritz Adjustable Intralumenal Appl. Set Basic Rotte Endometrial Applicator Set MUPIT Applicator Set Horiot Endometrial Applicator Set Norman Simon Applicator Set Standard Shielded Applicator Set Bonvoisin-Gerard Applicator Set Brain, Flexible Implant Needle Set Novi Sad Inflatable Rectal Applicator Set Catheter Insertion Set, 6F Trocar Nasopharyngeal Applicator Set NAG Brachyflex Set Catheter Insertion Set, 6F Bevel Demanes Rodriquez Applicator Set Ring Applicator Set Rotte Endometrial Applicator Set Lumencath Applicator Set Speiser Needle Insertion System Pipard Tounge Template Set Shielded Cylindrical Applicator Set Fritz Adjustable Intralumenal Applicator Set Fritz Adjustable Intralumenal Applicator Flexiguide Needle Set Super Mould Applicator Set Leipzig Applicator Set Selectron Standard Applicator Set Selectron Standard Shielded Applicator Set Pencil point needles Interstitial Needle Set Pancreatic Flexible Needle Set Martinez Endometrial Applicator Set Brain Needle Set with Fixing Tool Miami Vaginal Applicator Set Porter Perineal Applicator Set Arnhem Bile Duct Applicator Bladder Applicator Set Basic Norman Simon Applicator Set Trocar needles Flexible Implant Tube Set Rowland Oesophageal Applicator Set Henschke Applicator Set Houdek Applicator Set Bevel needles Catheter Deflection Set Template Set, Breast Implants (complete) Rotte Applicator Set Vaginal Applicator Set Oesophageal Applicator Set Standard Nasopharyngeal Applicator Set Interstitial Needle Basic Set Surface Mould Applicator Set Luneray Geneva Rectal Applicator OncoSelect HDR microSelectron HDR microSelectron Digital OncoSelect PDR microSelectron PDR microSelectron V3 TROCAR POINT TITANIUM NEEDLE SETS ROUND POINT TITANIUM NEEDLE SETS LumenCare Azure Prostate Stepper Template Set FLETCHER CT/MR SHIELDED APPLICATOR SET Martinez Prostate Template Set

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device