RAYENCE CO., LTD.

Korea, Republic · Hwaseong-Si

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, 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

7listed device types

Class I 1Class II 6Class III 0

plus 40 registration records and 39 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

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

3active device licences

Class II 3

12 including historic records

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 3Class 2b 4

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 States40 registration records, 39 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: RAYENCE CO., LTD. · RAYENCE CO. LTD. · Rayence Co., Ltd.

FDA 510(k) clearances by year

12011

22012

52013

62014

52015

32016

42017

22019

22020

32021

12022

12023

22024

12025

12026

FDA listed device types

System, Image Processing, Radiological 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Full Field Digital, System, X-Ray, Mammographic 1Bracket, Ceramic, Orthodontic 1System, X-Ray, Extraoral Source, Digital 1System, X-Ray, Fluoroscopic, Image-Intensified 1Bracket, Metal, Orthodontic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253800	0909FCE, 0909FCE-HS	2026-07-31
US	K243849	2430TCA with Xmaru W	2025-03-12
US	K242394	Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)	2024-09-09
BR	81756789001	Detector de raios X de painel plano digital	Class II
BR	80900480004	DIGITALIZADOR DE IMAGENS RADIOGRÁFICAS	Class I
BR	80900480005	SENSOR PARA RADIOGRAFIA DIGITAL ODONTOLÓGICA	Class II
CA	79642	DIGITAL FLAT PANEL X-RAY DETECTOR XMARU 1717	Class II
CA	79643	DIGITAL FLAT PANEL X-RAY DETECTOR XMARU 1210	Class II
CA	87854	MEDICAL IMAGE PROCESSING UNIT	Class II

RAYENCE 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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