RAY CO., LTD

Korea, Republic · Yongin-Si

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, 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

10listed device types

Class I 4Class II 6Class III 0

plus 23 registration records and 24 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

9 including historic records

TWTaiwanTFDA

10valid device licences

Class I 1Class II 9

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 1IIa 2IIb 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

3active registrations

Class 2b 3

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 States23 registration records, 24 510(k), 0 PMA, 83 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia1 confirmed, 5 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: RAY CO., LTD, · RAY CO., LTD. · Ray Co., Ltd.

FDA 510(k) clearances by year

42013

32015

22016

32018

22019

22021

22023

22024

32025

12026

FDA listed device types

showing 8 of 10

System, Image Processing, Radiological 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Orthodontic Software 1X-Ray, Tomography, Computed, Dental 1Unit, X-Ray, Intraoral 1System, X-Ray, Extraoral Source, Digital 1Accessories, Implant, Dental, Endosseous 1Tray, Impression, Preformed 1

Market	Identifier	Name	Class / date
US	K260462	RCT800	2026-04-09
US	K251798	RCT700	2025-11-25
US	K251109	SMARTDent	2025-05-21
SA	ME0000009875SFDAA00008	Raydent SG	—
CA	94113	RIOSENSOR	Class II

RAY CO., LTD

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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