FDA.reportPublic FDA data

NUCLETRON B.V.

Matched from indexed company URL: Nucletron B.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96118943002807741NUCLETRON B.V.1N2026-01-013900 AX VEENENDAAL, P.O. BOX 930 Waardgelder 1 VEENENDAAL Utrecht NL 3905 TH

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08717213054363Luneray - Catheter 6F 50cm, needle 37mm R30mm+1(770)300-9725info.america@elekta.com
08717213054370Luneray - Catheter 6F 50cm, needle 47mm R45mm+1(770)300-9725info.america@elekta.com
08717213054387Luneray - Catheter 6F 50cm, needle 57mm R60mm+1(770)300-9725info.america@elekta.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
106351932532681K983341STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SEJAQ1999-04-15
106351403192205K983338FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095JAQ1999-04-20
106351991412913K983337ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068JAQ1999-04-02
106351312197263K953946MICROSELECTRON-HDR VERSION 2JAQ1996-08-13
106351038344988K251037Rectal ApplicatorJAQ2025-12-19
106351630022004K213942EsteyaJAD2022-01-11
106351565145546K201272GenevaJAQ2020-07-16
106351400911670K171123Leksell Vantage Stereotactic SystemHAW2017-09-15
106351899636263K161688Advanced Gynecological ApplicatorJAQ2017-01-27
106351736207276K151272Henschke Titanium Applicator SetJAQ2015-06-23
106351407943143K142439Martinez Prostate Template SetJAQ2015-03-10
106351819917805K140803LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMJAQ2014-06-26
106351366090328K132889FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)JAQ2014-02-26
106351652627301K132874LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CMJAQ2014-02-21
106351463404409K132816ONCENTRA BRACHYMUJ2014-06-13
106351863235334K132092ESTEYAJAD2013-09-26
106351725679043K121448ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHYMUJ2012-07-02
106351617175547K112420ONCENTRA PROSTATE 4.0JAQ2011-11-18
106351984314690K111973VAGINAL CT / MR MULTI CHANNEL APPLICATOR SETJAQ2011-09-21
106351110092000K092804MICROSELECTRON HDR V2, MODEL 105.999JAQ2009-10-08
106351427634407K091154UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330,JAQ2009-05-18
106351458102671K090706ONCENTRA SIMULATION 2.3KPQ2009-06-15
106351065061894K082530APPLICATORS FOR AFTERLOADING BRACHYTHERAPYJAQ2008-10-30
106351358055875K080934VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SETJAQ2008-05-28
106351040978152K080871TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETSJAQ2008-04-29
106352033520390K073107VALENCIA SKIN APPLICATOR SET, MODEL: 189.701JAQ2007-12-07
106351518908587K072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALKPQ2007-09-14
106351983707144K070574FLEXITRONJAQ2007-04-13
106351431948610K061354MICROSELECTRON V3, MODEL 106.990JAQ2006-08-17
106351339789745K060349PROGUIDE NEEDLE SETJAQ2006-03-10
106351168276588K052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAMKPQ2005-10-24
106351427137096K052228SMIT SLEEVEJAQ2005-11-09
106351492525616K041715INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001JAQ2005-03-24
106351303942753K032372NUCLETRON COMFORT CATHETER SYSTEM, MODEL 189.007JAQ2003-08-15
106351217399892K022635KUSKE BREAST APPLICATOR SET, MODEL 189.006JAQ2002-09-06
106351022262948K010032SEED SELECTRON MODEL V. 1.0JAQ2001-10-17
106351284466537K003270PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067JAQ2000-12-22
106351036671853K002429SELECT SEED I-125KXK2001-02-02
106351453481708
106351653489802
106351881089475

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAQ292025-12-19
KPQ32009-06-15
JAD22022-01-11
MUJ22014-06-13
HAW12017-09-15
KXK12001-02-02

PMN#

Esteya

2022-01-11

Nucletron B.V.

ESTEYA

2013-09-26

NUCLETRON B.V.

GUDID#

200 records. Showing 1-40. Next