DRGEM CORPORATION

Korea, Republic · Gwangmyeong-Si

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, 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

9listed device types

Class I 3Class II 6Class III 0

plus 16 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

14 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 1IIb 10

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

4active registrations

Class 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 States16 registration records, 14 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: DRGEM CORPORATION

FDA 510(k) clearances by year

12010

52019

32020

12023

12024

22025

12026

FDA listed device types

showing 8 of 9

Holder, Radiographic Cassette, Wall-Mounted 1Generator, High-Voltage, X-Ray, Diagnostic 1Tube Mount, X-Ray, Diagnostic 1System, Image Processing, Radiological 1Table, Radiographic, Non-Tilting, Powered 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1System, X-Ray, Stationary 1

Market	Identifier	Name	Class / date
US	K260085	RAYMO Mobile X-ray System (Model: RAYMO)	2026-05-14
US	K251443	PROMO	2025-08-22
US	K242019	GXR-Series Diagnostic X-Ray System	2025-01-07

DRGEM 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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