Drgem Corp

FDA Filings

This page includes the latest FDA filings for Drgem Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

263690

DUNS 688477319

FDA Registration(s)

• Registration Number: 3006551157
• FEI Number: 3006551157
• Name: DRGEM CORPORATION
• Owner & Operator: DRGEM CORPORATION
• Contact Address: 116-59, Sanho-daero ; Gumi-si KR-47 Gyeongsangbugdo 730-906 KR
• Official Correspondent:
  • JUNG BYUNG - PARK
  • 82-70-82308560-x
• US Agent:
  • Won Young Choi
  • DRGEM USA inc
  • 201 3706672
  • drgemusa@gmail.com
• Importing Logistics Registration:
  • Importer: DRGEM USA INC
  • Address: 7018 NW 50th Terrace Gainesville Florida ; Gainesville, FL 32653 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7F. E-B/D Gwangmyeong Techno-Park, 60 Haan-ro ; Gwangmyeong-si Gyeonggido, 14322 KR
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3013095958
• FEI Number: 3013095958
• Name: Won Young Choi
• Owner & Operator: DRGEM CORPORATION
• Contact Address: 116-59, Sanho-daero ; Gumi-si KR-47 Gyeongsangbugdo 730-906 KR
• Official Correspondent:
  • JUNG BYUNG - PARK
  • 82-70-82308560-x
• US Agent:
  • Won Young Choi
  • DRGEM USA inc
  • 201 3706672
  • drgemusa@gmail.com
• Importing Logistics Registration:
  • Importer: DRGEM USA INC
  • Address: 7018 NW 50th Terrace Gainesville Florida ; Gainesville, FL 32653 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7018 NW 50th Terrace ; Gainesville, FL 32653 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800011150112 DRGEM Corporation	DRGEM	2025-09-03
GUDID 08800011150105 DRGEM Corporation	DRGEM	2025-09-03
GUDID 08800011110567 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110550 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110543 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110536 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110529 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110512 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110505 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110499 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110482 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110475 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110468 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110451 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110444 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011110437 DRGEM Corporation	DRGEM	2025-06-05
GUDID 08800011101145 DRGEM Corporation	DRGEM	2025-02-19
GUDID 08800011103170 DRGEM Corporation	DRGEM	2024-11-01
GUDID 08800011103163 DRGEM Corporation	DRGEM	2024-11-01
GUDID 08800011103132 DRGEM Corporation	DRGEM	2024-11-01
GUDID 08800011103125 DRGEM Corporation	DRGEM	2024-11-01
GUDID 08800011103095 DRGEM Corporation	DRGEM	2024-11-01
GUDID 08800011103088 DRGEM Corporation	DRGEM	2024-11-01
GUDID 08800011170028 DRGEM Corporation	DRGEM	2024-10-25
GUDID 00880001117002 DRGEM Corporation	DRGEM	2024-09-17
GUDID 08800011121914 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121907 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121891 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121884 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121877 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121808 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121792 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121785 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121778 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121761 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121679 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121662 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121655 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011121648 DRGEM Corporation	GXR-ES,ECS Diagnostic X-ray System	2023-11-06
GUDID 08800011103057 DRGEM Corporation	DRGEM	2021-08-09
GUDID 08800011103033 DRGEM Corporation	DRGEM	2021-08-09
GUDID 08800011103026 DRGEM Corporation	DRGEM	2021-08-09
GUDID 08800011103019 DRGEM Corporation	DRGEM	2021-08-09
GUDID 08800011103002 DRGEM Corporation	DRGEM	2021-08-09
GUDID 08800011140083 DRGEM Corporation	DRGEM	2020-12-15
GUDID 08800011170004 DRGEM Corporation	DRGEM	2020-11-05
PMN K202572 DRGEM Corporation	GXR-Series Diagnostic X-Ray System	2020-09-24
PMN K202156 DRGEM Corporation	DIAMOND-5A/6A/8A	2020-09-10
GUDID 08800011140885 DRGEM Corporation	DRGEM	2020-07-22
GUDID 08800011140168 DRGEM Corporation	DRGEM	2020-05-26
GUDID 08800011140151 DRGEM Corporation	DRGEM	2020-05-26
GUDID 08800011140014 DRGEM Corporation	DRGEM	2020-05-26
GUDID 08800011140007 DRGEM Corporation	DRGEM	2020-05-26
PMN K201124 DRGEM Corporation	TOPAZ Mobile DR System	2020-05-19
GUDID 08800011100018 DRGEM Corporation	DRGEM	2019-10-28
PMN K192453 | KPR Won Young Choi [DRGEM CORPORATION]	DIAMOND-5A, DIAMOND-6A, DIAMOND-8A,	2019-10-17
PMN K192453 | KPR DRGEM CORPORATION	DIAMOND-5A, DIAMOND-6A, DIAMOND-8A,	2019-10-17
GUDID 08800011120474 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120467 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120450 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120443 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120436 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120429 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120412 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120405 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120399 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120382 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120375 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120368 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120351 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120344 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120337 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120320 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120313 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120306 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120290 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120283 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120276 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120269 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120252 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120245 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120238 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120221 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120214 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120207 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120191 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120184 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120177 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120160 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120153 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120146 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120139 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120122 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120115 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120108 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120092 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120085 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120078 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120061 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120054 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120047 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120030 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120023 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120016 DRGEM Corporation	DRGEM	2019-10-10
GUDID 08800011120009 DRGEM Corporation	DRGEM	2019-10-10
PMN K192453 DRGEM Corporation	DIAMOND-5A/6A/8A	2019-10-01
PMN K192364 DRGEM Corporation	GXR-Series Diagnostic X-Ray System	2019-09-26
PMN K192364 | KPR Won Young Choi [DRGEM CORPORATION]	SGXR-32S, SGXR-40S, SGXR-52S, SGXR-68S, SGXR-82S, SGXR-C32S, SGXR-C40S, SGXR-C52S, SGXR-U32S, SGXR-U40S	2019-09-26
PMN K192364 | KPR Won Young Choi [DRGEM CORPORATION]	GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD	2019-09-26
PMN K192364 | KPR Won Young Choi [DRGEM CORPORATION]	GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S	2019-09-26
PMN K192364 | KPR Won Young Choi [DRGEM CORPORATION]	FDR Clinica FGXR-C32S, FDR Clinica FGXR-C40S, FDR Clinica FGXR-C52S, FDR Clinica FGXR-U32S, FDR Clinica FGXR-U40S	2019-09-26
PMN K192364 | KPR Won Young Choi [DRGEM CORPORATION]	FDR Clinica FGXR-32S, FDR Clinica FGXR-40S, FDR Clinica FGXR-52S, FDR Clinica FGXR-68S, FDR Clinica FGXR-82S	2019-09-26
PMN K192364 | KPR DRGEM CORPORATION	SGXR-32S, SGXR-40S, SGXR-52S, SGXR-68S, SGXR-82S, SGXR-C32S, SGXR-C40S, SGXR-C52S, SGXR-U32S, SGXR-U40S	2019-09-26
PMN K192364 | KPR DRGEM CORPORATION	GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD	2019-09-26
PMN K192364 | KPR DRGEM CORPORATION	GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S	2019-09-26
PMN K192364 | KPR DRGEM CORPORATION	FDR Clinica FGXR-C32S, FDR Clinica FGXR-C40S, FDR Clinica FGXR-C52S, FDR Clinica FGXR-U32S, FDR Clinica FGXR-U40S	2019-09-26
PMN K192364 | KPR DRGEM CORPORATION	FDR Clinica FGXR-32S, FDR Clinica FGXR-40S, FDR Clinica FGXR-52S, FDR Clinica FGXR-68S, FDR Clinica FGXR-82S	2019-09-26
PMN K183292 | IZL Won Young Choi [DRGEM CORPORATION]	TOPAZ-32D, TOPAZ-40D	2019-05-16
PMN K183292 | IZL DRGEM CORPORATION	TOPAZ-32D, TOPAZ-40D	2019-05-16
PMN K183292 DRGEM Corporation	Topaz Mobile DR System	2019-05-15
PMN K182537 | LLZ Won Young Choi [DRGEM CORPORATION]	RADMAX	2019-03-10
PMN K182537 | LLZ DRGEM CORPORATION	RADMAX	2019-03-10
PMN K182537 DRGEM Corporation	RADMAX Digital Imaging Software	2019-03-08
PMN K183388 | IZL Won Young Choi [DRGEM CORPORATION]	JADE-32, JADE-40	2019-02-07
PMN K183388 | IZL DRGEM CORPORATION	JADE-32, JADE-40	2019-02-07
PMN K183388 DRGEM Corporation	JADE Mobile X-Ray	2019-02-05
IZX Won Young Choi [DRGEM CORPORATION]	DXC-RML	2018-07-19
IZX Won Young Choi [DRGEM CORPORATION]	DXC-RMH	2018-07-19
IZX DRGEM CORPORATION	DXC-RML	2018-07-19
IZX DRGEM CORPORATION	DXC-RMH	2018-07-19
PMN K102408 | KPR Won Young Choi [DRGEM CORPORATION]	DIAMOND-5A, DIAMOND-6A,DIAMOND-8A	2011-01-11
PMN K102408 | KPR DRGEM CORPORATION	DIAMOND-5A, DIAMOND-6A,DIAMOND-8A	2011-01-11
PMN K102408 DRGEM CORPORATION	DIGITAL DIAGNOSTIC X-RAY SYSTEM	2010-12-27
IZZ Won Young Choi [DRGEM CORPORATION]	PBT-6	2009-09-04
IZZ Won Young Choi [DRGEM CORPORATION]	PBT-4	2009-09-04
IZZ Won Young Choi [DRGEM CORPORATION]	PBT-1	2009-09-04
IZZ DRGEM CORPORATION	PBT-6	2009-09-04
IZZ DRGEM CORPORATION	PBT-4	2009-09-04
IZZ DRGEM CORPORATION	PBT-1	2009-09-04
IYB Won Young Choi [DRGEM CORPORATION]	TS-FM6	2009-09-04
IYB Won Young Choi [DRGEM CORPORATION]	TS-FC6	2009-09-04
IYB Won Young Choi [DRGEM CORPORATION]	TS-FC4	2009-09-04
IYB Won Young Choi [DRGEM CORPORATION]	TS-FC2	2009-09-04
IYB Won Young Choi [DRGEM CORPORATION]	TS-CSP	2009-09-04
IYB Won Young Choi [DRGEM CORPORATION]	TS-CSE	2009-09-04
IYB Won Young Choi [DRGEM CORPORATION]	TS-CSA	2009-09-04
IYB DRGEM CORPORATION	TS-FM6	2009-09-04
IYB DRGEM CORPORATION	TS-FC6	2009-09-04
IYB DRGEM CORPORATION	TS-FC4	2009-09-04
IYB DRGEM CORPORATION	TS-FC2	2009-09-04
IYB DRGEM CORPORATION	TS-CSP	2009-09-04
IYB DRGEM CORPORATION	TS-CSE	2009-09-04
IYB DRGEM CORPORATION	TS-CSA	2009-09-04
IXY Won Young Choi [DRGEM CORPORATION]	WBS	2009-09-04
IXY Won Young Choi [DRGEM CORPORATION]	WBS-TM	2009-09-04
IXY Won Young Choi [DRGEM CORPORATION]	WBS-TA	2009-09-04
IXY DRGEM CORPORATION	WBS	2009-09-04
IXY DRGEM CORPORATION	WBS-TM	2009-09-04
IXY DRGEM CORPORATION	WBS-TA	2009-09-04
IZO Won Young Choi [DRGEM CORPORATION]	MXR-35	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-U40	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-U32	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-C52	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-C40	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-C32	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-82	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-68	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-52	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-40	2007-05-11
IZO Won Young Choi [DRGEM CORPORATION]	GXR-32	2007-05-11
IZO DRGEM CORPORATION	MXR-35	2007-05-11
IZO DRGEM CORPORATION	GXR-U40	2007-05-11
IZO DRGEM CORPORATION	GXR-U32	2007-05-11
IZO DRGEM CORPORATION	GXR-C52	2007-05-11
IZO DRGEM CORPORATION	GXR-C40	2007-05-11
IZO DRGEM CORPORATION	GXR-C32	2007-05-11
IZO DRGEM CORPORATION	GXR-82	2007-05-11
IZO DRGEM CORPORATION	GXR-68	2007-05-11
IZO DRGEM CORPORATION	GXR-52	2007-05-11
IZO DRGEM CORPORATION	GXR-40	2007-05-11
IZO DRGEM CORPORATION	GXR-32	2007-05-11

Related Finance Registrations

NCAGE Code	389FF	DRGEM CORPORATION
CAGE Code	389FF	DRGEM CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092531768	Pusan,South Korea -> Savannah, Georgia	PORTABLE X-RAY SYSTEM VETERINARY RADIOGRAPHIC SYSTEM PART FOR X-RAY EQUIPMENT 9022.14-1090 9022.21-2000 9022.90-9010 9030.10-0000	8 PKG
2020090119520	Pusan,South Korea -> Houston, Texas	40 WOODEN CASES OFDIAGNOSTIC X-RAY EQUIPMEN TMODEL: GXR-40S GXR-C40S GXR-E25 S INVOICE NO. AND DATE: DRG2006S266IRX 02 JUN 2020 H.S CODE:9022.14-1090	40 WDC
2020090119520	Pusan,South Korea -> Houston, Texas	40 WOODEN CASES OFDIAGNOSTIC X-RAY EQUIPMEN TMODEL: GXR-40S GXR-C40S GXR-E25 S INVOICE NO. AND DATE: DRG2006S266IRX 02 JUN 2020 H.S CODE:9022.14-1090	40 WDC
202008146517	Pusan,South Korea -> Charleston, South Carolina	18 WOODEN CASES OFDIAGNOSTIC X-RAY EQUIPMEN TMODEL : GXR-40S INVOICE NO. AND DATE: DR G2006S300BRX 26 JUN 2020 H.S CODE:9022.14-1 090	18 WDC
2020071316936	Pusan,South Korea -> Houston, Texas	20 W/BOXES OFPORTABLE X-RAY SYSTEMINVOICE NO : DRG2006S266IRX	20 WDC
2020070831664	Pusan,South Korea -> Houston, Texas	20 W/BOXES OFPORTABLE X-RAY SYSTEMINVOICE NO : DRG2006S266IRX	20 WDC
2020070720256	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	VETERINARY X-RAY SYSTEM	2 PKG
2020070637936	Pusan,South Korea -> Long Beach, California	DIAGNOSTIC X RAY SYSTEM	30 CAS
2020070638111	Pusan,South Korea -> Long Beach, California	PORTABLE X RAY SYSTEM DIGITAL IMAGING SYSTEM	7 PKG