NUCLETRON B.V.

Netherlands · Veenendaal

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 4Class III 0

plus 35 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

17active device licences

Class III 17

65 including historic records

TWTaiwanTFDA

5valid device licences

Class I 1Class II 4

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

3valid listings

Class II 2Class III 1

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

5active registrations

Class 2b 5

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States35 registration records, 12 510(k), 0 PMA, 6 excluded

Canada17 confirmed, 0 excluded

Manufacturer names merged into this page: NUCLETRON B.V.

FDA 510(k) clearances by year

12013

42014

22015

12017

12020

12022

12025

12026

FDA listed device types

System, Applicator, Radionuclide, Remote-Controlled 1Neurological Stereotaxic Instrument 1System, Therapeutic, X-Ray 1System, Planning, Radiation Therapy Treatment 1System, X-Ray, Film Marking, Radiographic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262383	LumenCare Azure	2026-07-24
US	K251037	Rectal Applicator	2025-12-19
US	K213942	Esteya	2022-01-11
CA	1323	THERAPLAN PLUS	Class III
CA	13032	PLATO BPS MLDR AND PLATO VIRTUAL SIMULATION SYSTEM (VSS)	Class III
CA	13417	PLATO BRACHYTHERAPY REMOTE AFTERLOADING SYSTEM	Class III

NUCLETRON B.V.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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