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SUN NUCLEAR CORPORATION

USA · Melbourne

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia, Israel, Russia — 8 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

11listed device types

Class I 6Class II 5Class III 0

plus 28 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

4 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

27active device licences

Class II 27

53 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 3

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

24active ARTG entries

Class I 19IIb 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States28 registration records, 24 510(k), 0 PMA, 33 excluded

Brazil2 confirmed, 1 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada27 confirmed, 4 excluded

Manufacturer names merged into this page: SUN NUCLEAR CORPORATION · Sun Nuclear Corporation · SUN NUCLEAR CO.

FDA 510(k) clearances by year

11988

22000

32001

22002

12005

12006

12009

12010

12012

32013

32014

22015

22016

12017

FDA listed device types

showing 8 of 11

System, Planning, Radiation Therapy Treatment 1System, Nuclear Magnetic Resonance Imaging 1Accelerator, Linear, Medical 1System, Radiation Therapy, Charged-Particle, Medical 1System, Radiation Therapy, Radionuclide 1Phantom, Test-Pattern, Radionuclide 1Phantom, Anthropomorphic, Radiographic 1Instrument, Quality-Assurance, Radiologic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170307	SunCHECK	2017-10-25
US	K161946	DoseCHECK	2016-09-16
US	K160057	ArcCHECK-MR	2016-05-13
BR	80102519107	Fantomas Gammex (ultrassom doppler)	Class II
BR	80102519111	Fantomas Gammex	Class II
SA	ME0000008415SFDAA00019	StereoPHAN	—
SA	ME0000008415SFDAA00020	SNC Phantoms™	—
CA	100017	MULTI-ENERGY CT PHANTOM	Class II
CA	100019	MODULAR DBT PHANTOM FOR BREAST TOMOSYNTHESIS	Class II
CA	100889	MAMMO 156D STEREO PHANTOM	Class II

SUN NUCLEAR CORPORATION

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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