FDA.reportPublic FDA data

SHINA CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80406193002808190SHINA CORP.1N2026-01-018-26, BOJEOKDONG-GIL, USEONG-MYEON, GONGJU-SI Chungnam KR 32533
30044584813004458481SHINA MED CORPORATION1N2026-01-01455-30, Bogaewonsam-ro Bogae-myeon Anseong-si Gyeonggi KR 17509

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
112521985135241K994230ULTICARE DISPOSABLE SYRINGEFMF2000-03-24
1815631307214089K984017ALLISON MEDICAL INSULIN SYRINGE (AMIS)FMF1999-03-04
112521256697927K875148MEDICRAT, HYPODERMIC SYRINGES & NEEDLESFMF1988-02-11
112521494817461K861153DISPOSABLE SYRINGES AND HYPODERMIC NEEDLESFMF1986-04-23
1815631912281579K250658SureFine Pen NeedleFMI2025-04-03
1815631075800953K250510Sure-Fine Insulin SyringesFMF2025-10-15
1815631961203821K231165Shina Syringe; Shina Safety SyringeMEG2023-10-27
112521935121656K222417Shina Safety NeedleFMI2023-03-20
1815631856328842K191531Sure-Fine Insulin SyringesFMF2019-09-06
1815631613526239K152879Sure-Fine Insulin SyringesFMF2016-09-09
1815631482527607K152877SureFine Pen NeedleFMI2016-06-07
112521348524606K140949ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLEMEG2015-02-09
112521491199950K124037JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLEFMF2013-09-12
1815631195010017K113186STERILE INSULIN PEN NEEDLEFMI2012-04-12
112521273778457K113186STERILE INSULIN PEN NEEDLEFMI2012-04-12
112521267876593K103011ULTICARE SAFETY INSULIN SYRINGEMEG2011-02-02
1815631006473913K091167SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGESFMF2009-08-06
112521738807489K091167SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGESFMF2009-08-06
112522015536539K080600ULTIMED ULTICARE SAFETY SYRINGEMEG2008-06-25
112521488301510K071947VACU-MED BLOOD COLLECTION NEEDLESFMI2007-10-12
112522017330598K062702ULTICARE DISPOSABLE SYRINGES AND NEEDLESFMF2006-11-29
112522036915966K033794ULTICARE DISPOSABLE SYRINGE 3 ML/CCFMF2003-12-30
1815631144791063
1815631279012151
1815631279997899
112521446854222
1815631456215951
1815631462702984
112521562219974
112521928728042

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMF122025-10-15
FMI62025-04-03
MEG42023-10-27

PMN#

3DI

2012-02-16

SHINA SYSTEMS LTD.

3DI

2010-01-19

SHINA SYSTEMS LTD.

GUDID#

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