Nucletron B V

FDA Filings

This page includes the latest FDA filings for Nucletron B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9611894
FEI Number3002807741
NameThomas Valentine
Owner & OperatorNucletron B.V.
Contact Address3900 Ax Veenendaal, P.O. Box 930 Waardgelder 1
Veenendaal NL-UT Utrecht 3905 TH NL
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400 Perimeter Center Terrace, Suite 50
ATL, GA 30346 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Nucletron B.V.
 Luneray 2022-11-23
Nucletron B.V.
 Luneray 2022-11-23
Nucletron B.V.
 Luneray 2022-11-23
Nucletron B.V.
 Luneray 2022-11-15
Nucletron B.V.
 Esteya 2022-08-24
Nucletron B.V.
 2022-07-08
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 2022-06-10
Nucletron B.V.
 2022-06-10
Nucletron B.V.
 2022-06-10
Nucletron B.V.
 2022-06-10
Nucletron B.V.
 2022-06-10
Nucletron B.V.
 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
 X-ray Catheters 2022-06-10
Nucletron B.V.
Esteya2022-01-11
Nucletron BV
Geneva2020-07-16
Thomas Valentine [Nucletron B.V.]
Leksell Vantage Stereotactic System2018-09-13
Thomas Valentine [Nucletron B.V.]
Leksell Stereotactic System2018-09-13
Thomas Valentine [Nucletron B.V.]
Advanced Gynecological Applicator2017-01-30
NUCLETRON BV
Advanced Gynecological Applicator2017-01-27
Thomas Valentine [Nucletron B.V.]
Henschke Titanium Applicator Set2015-06-24
NUCLETRON B.V.
Henschke Titanium Applicator Set2015-06-23
Thomas Valentine [Nucletron B.V.]
Martinez Prostate Template Set2015-03-11
Nucletron BV
Martinez Prostate Template Set2015-03-10
Thomas Valentine [Nucletron B.V.]
CT Markers Set2014-12-17
Thomas Valentine [Nucletron B.V.]
Luneray2014-07-01
NUCLETRON B.V.
LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM2014-06-26
Thomas Valentine [Nucletron B.V.]
Oncentra Brachy2014-06-20
NUCLETRON B.V.
ONCENTRA BRACHY2014-06-13
Thomas Valentine [Nucletron B.V.]
FLETCHER CT/MR SHIELDED APPLICATOR SET2014-05-13
NUCLETRON B.V.
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)2014-02-26
Thomas Valentine [Nucletron B.V.]
LumenCare Azure2014-02-25
NUCLETRON B.V.
LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM2014-02-21
Thomas Valentine [Nucletron B.V.]
Esteya2013-10-28
NUCLETRON B.V.
ESTEYA2013-09-26
Thomas Valentine [Nucletron B.V.]
ProGuide Needle2012-12-17
Thomas Valentine [Nucletron B.V.]
check cable2012-07-13
Thomas Valentine [Nucletron B.V.]
Ir-192 Source2012-07-13
Thomas Valentine [Nucletron B.V.]
Smit Sleeve2012-07-13
Thomas Valentine [Nucletron B.V.]
Smit Sleeve CT/MR2012-07-13
Thomas Valentine [Nucletron B.V.]
VAGINAL CT/MR APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
STANDARD CT/MR APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
RING CT/MR APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
Fletcher CT/MR Applicator Set2012-07-06
Thomas Valentine [Nucletron B.V.]
Fletcher CT/MR Applicator Set XS2012-07-06
Thomas Valentine [Nucletron B.V.]
FLETCHER WILLIAMSON APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
FREIBURG FLAP APPLICATOR SET2012-07-06
Thomas Valentine [Nucletron B.V.]
ROTTERDAM NASOPHARYNX MOULD SET2012-07-06
Thomas Valentine [Nucletron B.V.]
Prostate Stepper Template Set2012-07-06
Thomas Valentine [Nucletron B.V.]
Oncentra2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Masterplan2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra External Beam2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Brachy2012-07-05
Thomas Valentine [Nucletron B.V.]
Masterplan2012-07-05
Thomas Valentine [Nucletron B.V.]
OncoSelect Stepper2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Seeds2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Prostate2012-07-05
Thomas Valentine [Nucletron B.V.]
Laptop Cart2012-07-05
Thomas Valentine [Nucletron B.V.]
ERCM - EndoCavity Rotational Mover2012-07-05
Thomas Valentine [Nucletron B.V.]
Utrecht Interstitial Fletcher CT/MR Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Utrecht Interstitial CT/MR Applicator set2012-07-05
Thomas Valentine [Nucletron B.V.]
MR Line Marker2012-07-05
Thomas Valentine [Nucletron B.V.]
Interstitial Ring CT/MR Applicator set2012-07-05
Thomas Valentine [Nucletron B.V.]
Guiding Tube for Ring Set for Interstitial Ring2012-07-05
Thomas Valentine [Nucletron B.V.]
Guiding Tube for Ovoids2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra Simulation2012-07-05
Thomas Valentine [Nucletron B.V.]
Vienna Ring CT/MR Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Trocar Point Titanium Needle Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Round Point Titanium Needle Set2012-07-05
Thomas Valentine [Nucletron B.V.]
TROCAR POINT TITANIUM NEEDLE SETS2012-07-05
Thomas Valentine [Nucletron B.V.]
ROUND POINT TITANIUM NEEDLE SETS2012-07-05
Thomas Valentine [Nucletron B.V.]
Valencia Skin Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Valencia Ft Skin Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL2012-07-05
Thomas Valentine [Nucletron B.V.]
IBU - Table2012-07-05
Thomas Valentine [Nucletron B.V.]
IBU - Digital2012-07-05
Thomas Valentine [Nucletron B.V.]
Simulix Evolution2012-07-05
Thomas Valentine [Nucletron B.V.]
Oncentra ConeBeam2012-07-05
Thomas Valentine [Nucletron B.V.]
INTRACAVITARY MOULD APPLICATOR SET2012-07-05
Thomas Valentine [Nucletron B.V.]
INTRACAVITARY MOULD APPLICATOR SET Ft2012-07-05
Thomas Valentine [Nucletron B.V.]
OncoSmart Flange Molding Set2012-07-05
Thomas Valentine [Nucletron B.V.]
OncoSmart Catheter System2012-07-05
Thomas Valentine [Nucletron B.V.]
Flexible Implant Tube2012-07-05
Thomas Valentine [Nucletron B.V.]
CT/MR OncoSmart Catheter Sets2012-07-05
Thomas Valentine [Nucletron B.V.]
Kuske Breast Template Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Kuske Breast Applicator Set2012-07-05
Thomas Valentine [Nucletron B.V.]
Breast CT/MR Template Set2012-07-05
Thomas Valentine [Nucletron B.V.]
selectSpacer2012-06-12
Thomas Valentine [Nucletron B.V.]
seedSelectron and accessories2012-06-12
Thomas Valentine [Nucletron B.V.]
disposable set2012-06-12
Thomas Valentine [Nucletron B.V.]
Vaginal CT/MR Multi Channel Applicator Set2011-09-26
Thomas Valentine [Nucletron B.V.]
Catheter Set with Collar 6Fx293 mm2011-09-26
Thomas Valentine [Nucletron B.V.]
Vaginal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Trocar needles2011-06-28
Thomas Valentine [Nucletron B.V.]
Template Set, Breast Implants (complete)2011-06-28
Thomas Valentine [Nucletron B.V.]
Surface Mould Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Super Mould Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Standard Shielded Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Standard Nasopharyngeal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Speiser Needle Insertion System2011-06-28
Thomas Valentine [Nucletron B.V.]
Shielded Cylindrical Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Selectron Standard Shielded Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Selectron Standard Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Rowland Oesophageal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Rotte Endometrial Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Rotte Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Ring Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Porter Perineal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Pipard Tounge Template Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Pencil point needles2011-06-28
Thomas Valentine [Nucletron B.V.]
Pancreatic Flexible Needle Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Oesophageal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Novi Sad Inflatable Rectal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Norman Simon Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Nasopharyngeal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
NAG Brachyflex Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Miami Vaginal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Martinez Endometrial Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
MUPIT Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Lumencath Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Leipzig Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Ir-192 source2011-06-28
Thomas Valentine [Nucletron B.V.]
Interstitial Needle Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Interstitial Needle Basic Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Houdek Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Horiot Endometrial Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Henschke Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Fritz Adjustable Intralumenal Applicator2011-06-28
Thomas Valentine [Nucletron B.V.]
Fritz Adjustable Intralumenal Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Fritz Adjustable Intralumenal Appl. Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Flexiguide Needle Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Flexible Implant Tube Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Demanes Rodriquez Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Catheter Insertion Set, 6F Trocar2011-06-28
Thomas Valentine [Nucletron B.V.]
Catheter Insertion Set, 6F Bevel2011-06-28
Thomas Valentine [Nucletron B.V.]
Catheter Deflection Set2011-06-28
Thomas Valentine [Nucletron B.V.]
CT/MR Applicator Clamp2011-06-28
Thomas Valentine [Nucletron B.V.]
Brain, Flexible Implant Needle Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Brain Needle Set with Fixing Tool2011-06-28
Thomas Valentine [Nucletron B.V.]
Bonvoisin-Gerard Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Bladder Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Bevel needles2011-06-28
Thomas Valentine [Nucletron B.V.]
Basic Rotte Endometrial Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Basic Norman Simon Applicator Set2011-06-28
Thomas Valentine [Nucletron B.V.]
Arnhem Bile Duct Applicator2011-06-28
Thomas Valentine [Nucletron B.V.]
Martinez Prostate Template set2010-11-22
Thomas Valentine [Nucletron B.V.]
Cervix Ring Applicator set2010-11-22
Thomas Valentine [Nucletron B.V.]
Bonvoisin Gerard Esophageal Applicator Set2010-11-22
Thomas Valentine [Nucletron B.V.]
X-ray markers2010-11-17
Thomas Valentine [Nucletron B.V.]
Vaginal Cylinder applicator2010-11-17
Thomas Valentine [Nucletron B.V.]
Transfer Tubes2010-11-17
Thomas Valentine [Nucletron B.V.]
Ti vaginal Cylinder applicator set2010-11-17
Thomas Valentine [Nucletron B.V.]
Source Position Check Ruler (SPCR)2010-11-17
Thomas Valentine [Nucletron B.V.]
Flexitron2010-11-17
Thomas Valentine [Nucletron B.V.]
Flexisource and Check Cable2010-11-17
Thomas Valentine [Nucletron B.V.]
Cervix Rotterdam Applicators2010-11-17
Thomas Valentine [Nucletron B.V.]
Bronchial Catheter Adapter2010-11-17
Thomas Valentine [Nucletron B.V.]
microSelectron V32008-10-16
Thomas Valentine [Nucletron B.V.]
microSelectron PDR2008-10-16
Thomas Valentine [Nucletron B.V.]
microSelectron HDR2008-10-16
Thomas Valentine [Nucletron B.V.]
microSelectron Digital2008-10-16
Thomas Valentine [Nucletron B.V.]
OncoSelect PDR2008-10-16
Thomas Valentine [Nucletron B.V.]
OncoSelect HDR2008-10-16
Thomas Valentine [Nucletron B.V.]
selectSeed I-1252006-09-06

Related Finance Registrations
NCAGE CodeH1E81NUCLETRON B.V.
CAGE CodeH1E81NUCLETRON B.V.
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