HomeKorea, RepublicGENORAY CO., LTD.

GENORAY CO., LTD.

Korea, Republic · Seongnam-Si Gyeonggi
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Israel, Russia — 7 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 0Class II 7Class III 0
plus 16 registration records and 24 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
6active ARTG entries
IIa 1IIb 5
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
10active registrations
Class 2a 1Class 2b 9
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 States16 registration records, 24 510(k), 0 PMA, 2 excluded
Manufacturer names merged into this page: GENORAY CO., LTD.

Company information

Country
Korea, Republic
City
Seongnam-Si Gyeonggi

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12007
12009
12010
22011
12012
22013
22014
12015
32018
12020
32022
32023
22025
12026

FDA listed device types

Image-Intensified Fluoroscopic X-Ray System, Mobile 1System, X-Ray, Extraoral Source, Digital 1Full Field Digital, System, X-Ray, Mammographic 1Interventional Fluoroscopic X-Ray System 1Unit, X-Ray, Extraoral With Timer 1X-Ray, Tomography, Computed, Dental 1System, X-Ray, Fluoroscopic, Image-Intensified 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252229BELLIGER ACE2026-04-02
USK250060GT300; GT300-C2025-10-08
USK243420HESTIA2025-07-17

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