FDA.reportPublic FDA data

M.I.Tech Co Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30081463313008146331M.I.Tech Co Ltd1N2026-01-01174, Habuk 2gil, Jinwimyeon Pyeongtaek Gyeonggi KR 17706

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1108991951328718K253327HANAROSTENT Esophagus Upper (CCC)ESW2025-10-30
1108991869527336K213251HANAROSTENT Esophagus Asymmetric (CCC)ESW2021-11-18
1108991205882227K202973HANAROSTENT Benefit Biliary (NNN)FGE2021-05-11
1108991315698722K201342HANAROSTENT Trachea/Bronchium (CCC)JCT2020-12-31
1108991864697460K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)ESW2021-07-23
1108991955386892K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)ESW2020-05-20
1108991950092319K190141HANAROSTENT LowAx Colon/Rectum (NNN)MQR2019-03-07
1108991860067370K183616HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)MQR2019-01-10
1108991576136384K183396HANAROSTENT FASTTM Biliary (NNN)FGE2019-02-11
1108991295398613K180180HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)MQR2018-11-02
1108991223795400K111149HANAROSTENT BILIARY (NNN)FGE2011-12-30
1108991642076417K093537HANAROSTENT ESOPHAGUS (CCC)ESW2010-06-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ESW52025-10-30
FGE32021-05-11
MQR32019-03-07
JCT12020-12-31