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 OFKOREA EXCHANGE (KOSDAQ)263690DUNS 688477319
FDA Registration(s)
Registration Number3006551157
FEI Number3006551157
NameDRGEM CORPORATION
Owner & OperatorDRGEM CORPORATION
Contact Address116-59, Sanho-daero
Gumi-si KR-47 Gyeongsangbugdo 730-906 KR
Official Correspondent
  • JUNG BYUNG - PARK
  • 82-70-82308560-x
US Agent
Importing Logistics Registration
ImporterDRGEM USA INC
Address7018 NW 50th Terrace Gainesville Florida
Gainesville, FL 32653 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7F. E-B/D Gwangmyeong Techno-Park, 60 Haan-ro
Gwangmyeong-si Gyeonggido, 14322 KR
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3013095958
FEI Number3013095958
NameWon Young Choi
Owner & OperatorDRGEM CORPORATION
Contact Address116-59, Sanho-daero
Gumi-si KR-47 Gyeongsangbugdo 730-906 KR
Official Correspondent
  • JUNG BYUNG - PARK
  • 82-70-82308560-x
US Agent
Importing Logistics Registration
ImporterDRGEM USA INC
Address7018 NW 50th Terrace Gainesville Florida
Gainesville, FL 32653 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address7018 NW 50th Terrace
Gainesville, FL 32653 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
DRGEM Corporation
DIAMOND-5A/6A/8A2020-09-10
DRGEM Corporation
DRGEM 2020-07-22
DRGEM Corporation
DRGEM 2020-05-26
DRGEM Corporation
DRGEM 2020-05-26
DRGEM Corporation
DRGEM 2020-05-26
DRGEM Corporation
DRGEM 2020-05-26
DRGEM Corporation
TOPAZ Mobile DR System2020-05-19
DRGEM Corporation
DRGEM 2019-10-28
Won Young Choi [DRGEM CORPORATION]
DIAMOND-5A, DIAMOND-6A, DIAMOND-8A,2019-10-17
DRGEM CORPORATION
DIAMOND-5A, DIAMOND-6A, DIAMOND-8A,2019-10-17
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DRGEM 2019-10-10
DRGEM Corporation
DIAMOND-5A/6A/8A2019-10-01
DRGEM Corporation
GXR-Series Diagnostic X-Ray System2019-09-26
Won Young Choi [DRGEM CORPORATION]
SGXR-32S, SGXR-40S, SGXR-52S, SGXR-68S, SGXR-82S, SGXR-C32S, SGXR-C40S, SGXR-C52S, SGXR-U32S, SGXR-U40S2019-09-26
Won Young Choi [DRGEM CORPORATION]
GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD2019-09-26
Won Young Choi [DRGEM CORPORATION]
GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S2019-09-26
Won Young Choi [DRGEM CORPORATION]
FDR Clinica FGXR-C32S, FDR Clinica FGXR-C40S, FDR Clinica FGXR-C52S, FDR Clinica FGXR-U32S, FDR Clinica FGXR-U40S2019-09-26
Won Young Choi [DRGEM CORPORATION]
FDR Clinica FGXR-32S, FDR Clinica FGXR-40S, FDR Clinica FGXR-52S, FDR Clinica FGXR-68S, FDR Clinica FGXR-82S2019-09-26
DRGEM CORPORATION
SGXR-32S, SGXR-40S, SGXR-52S, SGXR-68S, SGXR-82S, SGXR-C32S, SGXR-C40S, SGXR-C52S, SGXR-U32S, SGXR-U40S2019-09-26
DRGEM CORPORATION
GXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD2019-09-26
DRGEM CORPORATION
GXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S2019-09-26
DRGEM CORPORATION
FDR Clinica FGXR-C32S, FDR Clinica FGXR-C40S, FDR Clinica FGXR-C52S, FDR Clinica FGXR-U32S, FDR Clinica FGXR-U40S2019-09-26
DRGEM CORPORATION
FDR Clinica FGXR-32S, FDR Clinica FGXR-40S, FDR Clinica FGXR-52S, FDR Clinica FGXR-68S, FDR Clinica FGXR-82S2019-09-26
Won Young Choi [DRGEM CORPORATION]
TOPAZ-32D, TOPAZ-40D2019-05-16
DRGEM CORPORATION
TOPAZ-32D, TOPAZ-40D2019-05-16
DRGEM Corporation
Topaz Mobile DR System2019-05-15
Won Young Choi [DRGEM CORPORATION]
RADMAX2019-03-10
DRGEM CORPORATION
RADMAX2019-03-10
DRGEM Corporation
RADMAX Digital Imaging Software2019-03-08
Won Young Choi [DRGEM CORPORATION]
JADE-32, JADE-402019-02-07
DRGEM CORPORATION
JADE-32, JADE-402019-02-07
DRGEM Corporation
JADE Mobile X-Ray2019-02-05
Won Young Choi [DRGEM CORPORATION]
DXC-RML2018-07-19
Won Young Choi [DRGEM CORPORATION]
DXC-RMH2018-07-19
DRGEM CORPORATION
DXC-RML2018-07-19
DRGEM CORPORATION
DXC-RMH2018-07-19
Won Young Choi [DRGEM CORPORATION]
DIAMOND-5A, DIAMOND-6A,DIAMOND-8A2011-01-11
DRGEM CORPORATION
DIAMOND-5A, DIAMOND-6A,DIAMOND-8A2011-01-11
DRGEM CORPORATION
DIGITAL DIAGNOSTIC X-RAY SYSTEM2010-12-27
Won Young Choi [DRGEM CORPORATION]
PBT-62009-09-04
Won Young Choi [DRGEM CORPORATION]
PBT-42009-09-04
Won Young Choi [DRGEM CORPORATION]
PBT-12009-09-04
DRGEM CORPORATION
PBT-62009-09-04
DRGEM CORPORATION
PBT-42009-09-04
DRGEM CORPORATION
PBT-12009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-FM62009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-FC62009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-FC42009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-FC22009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-CSP2009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-CSE2009-09-04
Won Young Choi [DRGEM CORPORATION]
TS-CSA2009-09-04
DRGEM CORPORATION
TS-FM62009-09-04
DRGEM CORPORATION
TS-FC62009-09-04
DRGEM CORPORATION
TS-FC42009-09-04
DRGEM CORPORATION
TS-FC22009-09-04
DRGEM CORPORATION
TS-CSP2009-09-04
DRGEM CORPORATION
TS-CSE2009-09-04
DRGEM CORPORATION
TS-CSA2009-09-04
Won Young Choi [DRGEM CORPORATION]
WBS2009-09-04
Won Young Choi [DRGEM CORPORATION]
WBS-TM2009-09-04
Won Young Choi [DRGEM CORPORATION]
WBS-TA2009-09-04
DRGEM CORPORATION
WBS2009-09-04
DRGEM CORPORATION
WBS-TM2009-09-04
DRGEM CORPORATION
WBS-TA2009-09-04
Won Young Choi [DRGEM CORPORATION]
MXR-352007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-U402007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-U322007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-C522007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-C402007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-C322007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-822007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-682007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-522007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-402007-05-11
Won Young Choi [DRGEM CORPORATION]
GXR-322007-05-11
DRGEM CORPORATION
MXR-352007-05-11
DRGEM CORPORATION
GXR-U402007-05-11
DRGEM CORPORATION
GXR-U322007-05-11
DRGEM CORPORATION
GXR-C522007-05-11
DRGEM CORPORATION
GXR-C402007-05-11
DRGEM CORPORATION
GXR-C322007-05-11
DRGEM CORPORATION
GXR-822007-05-11
DRGEM CORPORATION
GXR-682007-05-11
DRGEM CORPORATION
GXR-522007-05-11
DRGEM CORPORATION
GXR-402007-05-11
DRGEM CORPORATION
GXR-322007-05-11

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