FDA.reportPublic FDA data

DRGEM CORPORATION

Matched from indexed company URL: DRGEM Corporation

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30065511573006551157DRGEM CORPORATION1N2026-01-017F. E-B/D Gwangmyeong Techno-Park, 60 Haan-ro Gwangmyeong-si Gyeongbuk KR 14322
30240828153024082815DRGEM AMERICA INC1Y2026-01-0113755 HUTTON DR Suite 500 Farmers Branch TX US 75234
30096705723009670572DRGEM USA INC1Y2020-04-257018 NW 50th Ter Gainesville FL US 32653

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2057631912333739K260085RAYMO Mobile X-ray System (Model: RAYMO)IZL2026-05-14
2057631490910495K251443PROMOIZL2025-08-22
2057632058677621K242019GXR-Series Diagnostic X-Ray SystemKPR2025-01-07
2057632030050936K242015TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)IZL2024-12-16
2057631585995410K232178GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)KPR2023-09-19
2057631222102652K202572GXR-Series Diagnostic X-Ray SystemKPR2020-09-24
2057631755098539K202156DIAMOND-5A/6A/8AKPR2020-09-10
2057631132136410K201124TOPAZ Mobile DR SystemIZL2020-05-19
2057631631231221K192453DIAMOND-5A/6A/8AKPR2019-10-01
2057632070148689K192364GXR-Series Diagnostic X-Ray SystemKPR2019-09-26
2057632071422516K183388JADE Mobile X-RayIZL2019-02-05
2057631549102216K183292Topaz Mobile DR SystemIZL2019-05-15
2057631527340881K182537RADMAX Digital Imaging SoftwareLLZ2019-03-08
2057631762260890K102408DIGITAL DIAGNOSTIC X-RAY SYSTEMKPR2010-12-27
2057631011762832
2057631068111374
2057631449194465
2057631451521739
2057631760429243

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPR82025-01-07
IZL72026-05-14
LLZ22019-03-08

PMN#

PROMO

2025-08-22

DRGEM Corporation

GUDID#

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