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iRay Imaging Technology Taicang Limited

China · Taicang Jiangsu

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 1Class II 8Class III 0

plus 32 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

11registered devices

Class I 2Class II 9

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States32 registration records, 25 510(k), 0 PMA, 3 excluded

Brazil11 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: iRay Imaging Technology Taicang Limited · IRAY IMAGING LLC · iRay Imaging Technology (Haining) Limited · IRAY TECHNOLOGY COMPANY LIMITED · IRAY TECHNOLOGY COMPANY LTD.

Same-named companies — This database also contains companies with near-identical names: IRAY IMAGING LLC, iRay Imaging Technology (Haining) Limited. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22018

32019

32020

42021

82022

32023

22025

FDA listed device types

showing 8 of 9

System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1System, X-Ray, Extraoral Source, Digital 1Collimator, Automatic, Radiographic 1Unit, X-Ray, Extraoral With Timer 1Collimator, Manual, Radiographic 1X-Ray, Tomography, Computed, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252911	Lux HD 2530 detector (Lux HD 2530)	2025-10-09
US	K243556	Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)	2025-03-18
US	K230998	Digital Wireless Intraoral X-Ray Sensor	2023-10-20
BR	80970159003	Detector Digital de Raios-X	Class II
BR	80348969005	SISTEMA RADIOGRÁFICO DIGITAL INTRAORAL	Class II
BR	80970150002	DETECTOR DIGITAL DE RAIOS-X IRAY	Class II

iRay Imaging Technology Taicang Limited

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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