M I Tech Co L T D

FDA Filings

This page includes the latest FDA filings for M I Tech Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

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DUNS 688454359

FDA Registration(s)

Registration Number	3011458193
FEI Number	3011458193
Name	M.I.Tech Co., Ltd.
Owner & Operator	M.I.Tech Co., Ltd.
Contact Address	174, habuk 2gil, jinwimyeon Pyeongtaek KR-41 Gyeonggido 17706 KR
Official Correspondent	Inae Kim 82-31-6625645-x
US Agent	Priscilla Chung TNS USA 714 9922595 juhee.c@lkconsultinggroup.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	1286-1, lui-dong, Yeongtong-gu Suwon-Si Gyeonggido, 16229 KR
Establishment Type	Manufacture Medical Device

Registration Number	3008146331
FEI Number	3008146331
Name	Priscilla Chung
Owner & Operator	M.I.Tech Co., Ltd.
Contact Address	174, habuk 2gil, jinwimyeon Pyeongtaek KR-41 Gyeonggido 17706 KR
Official Correspondent	Inae Kim 82-31-6625645-x
US Agent	Priscilla Chung LK Consulting Group USA, Inc. 714 2025789 juhee.c@lkconsultinggroup.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	1150 ROOSEVELT, SUITE 200 Irvine, CA 92620 US
Establishment Type	Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 08806367058249 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367046796 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367040350 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367024961 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367024824 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367024817 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367024800 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367024794 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367021830 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367021823 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367021816 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004222 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004215 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004208 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004192 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004185 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004178 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004161 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004147 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367004130 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (CCC)	2022-11-28
GUDID 08806367082053 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367082046 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367082039 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367082022 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073747 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073730 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073723 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073716 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073709 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073693 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073396 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073389 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073372 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073365 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073358 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073341 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073334 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367073327 M.I.Tech Co., Ltd.	HANAROSTENT® FAST^TM Biliary (NNN)	2022-04-08
GUDID 08806367047199 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047182 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047151 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047144 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047137 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047120 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047113 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047106 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047090 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047083 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047076 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047069 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047052 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047045 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047038 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367047021 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017642 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017628 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017611 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017604 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017598 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017581 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017574 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017567 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017468 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017444 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017437 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017420 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017413 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017406 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017390 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367017383 M.I.Tech Co., Ltd.	HANAROSTENT® Biliary (NNN)	2022-04-08
GUDID 08806367044563 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044556 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044549 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044532 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044525 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044518 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044501 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044495 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044440 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044433 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044426 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044419 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367044402 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367043351 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367040688 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039781 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039767 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039750 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039743 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039736 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039583 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039576 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039552 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039545 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039507 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039491 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367039484 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus (NCN)	2022-01-10
GUDID 08806367020376 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367020369 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
GUDID 08806367020352 M.I.Tech Co., Ltd.	HANAROSTENT® Esophagus Asymmetric (CCC)	2022-01-10
PMN K213251 M.I.Tech Co., Ltd.	HANAROSTENT Esophagus Asymmetric (CCC)	2021-11-18
PMN K201160 M.I. Tech Co., Ltd	HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)	2021-07-23
PMN K202973 M.I.Tech Co., Ltd.	HANAROSTENT Benefit Biliary (NNN)	2021-05-11
PMN K201342 M.I. Tech Co., Ltd.	HANAROSTENT Trachea/Bronchium (CCC)	2020-12-31
PMN K200860 M.I. Tech Co., Ltd	HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)	2020-05-20
PMN K190141 \| MQR Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Duodenum/Pylorus(NNN)	2019-03-08
PMN K190141 \| MQR Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAX Colon/Rectum(NNN)	2019-03-08
PMN K190141 \| MQR M.I.Tech Co., Ltd.	HANAROSTENT LowAx Duodenum/Pylorus(NNN)	2019-03-08
PMN K190141 \| MQR M.I.Tech Co., Ltd.	HANAROSTENT LowAX Colon/Rectum(NNN)	2019-03-08
PMN K190141 M.I.Tech Co., Ltd.	HANAROSTENT LowAx Colon/Rectum (NNN)	2019-03-07
PMN K183396 M.I.Tech Co., Ltd.	HANAROSTENT FASTTM Biliary (NNN)	2019-02-11
PMN K183396 \| FGE Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT? FAST? Biliary (NNN)	2019-02-11
PMN K183396 \| FGE M.I.Tech Co., Ltd.	HANAROSTENT? FAST? Biliary (NNN)	2019-02-11
PMN K183616 \| MUM Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2019-01-11
PMN K183616 \| MUM Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Colon/Rectum (NNN)	2019-01-11
PMN K183616 \| MUM M.I.Tech Co., Ltd.	HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2019-01-11
PMN K183616 \| MUM M.I.Tech Co., Ltd.	HANAROSTENT LowAx Colon/Rectum (NNN)	2019-01-11
PMN K183616 \| MQR Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2019-01-11
PMN K183616 \| MQR Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Colon/Rectum (NNN)	2019-01-11
PMN K183616 \| MQR M.I.Tech Co., Ltd.	HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2019-01-11
PMN K183616 \| MQR M.I.Tech Co., Ltd.	HANAROSTENT LowAx Colon/Rectum (NNN)	2019-01-11
PMN K183616 M.I. Tech Co., Ltd.	HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2019-01-10
PMN K180180 \| MUM Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2018-11-16
PMN K180180 \| MUM Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Colon/Rectum (NNN)	2018-11-16
PMN K180180 \| MUM M.I.Tech Co., Ltd.	HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2018-11-16
PMN K180180 \| MUM M.I.Tech Co., Ltd.	HANAROSTENT LowAx Colon/Rectum (NNN)	2018-11-16
PMN K180180 \| MQR Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2018-11-16
PMN K180180 \| MQR Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT LowAx Colon/Rectum (NNN)	2018-11-16
PMN K180180 \| MQR M.I.Tech Co., Ltd.	HANAROSTENT LowAx Duodenum/Pylorus (NNN)	2018-11-16
PMN K180180 \| MQR M.I.Tech Co., Ltd.	HANAROSTENT LowAx Colon/Rectum (NNN)	2018-11-16
PMN K180180 M.I. Tech Co., Ltd.	HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)	2018-11-02
PMN K160893 M.I.TECH CO.,LTD	HANAROCare ReJu	2016-07-27
PMN K111149 \| FGE Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT? Biliary (NNN)	2012-03-29
PMN K111149 \| FGE M.I.Tech Co., Ltd.	HANAROSTENT? Biliary (NNN)	2012-03-29
PMN K111149 M.I. TECH CO., LTD.	HANAROSTENT BILIARY (NNN)	2011-12-30
PMN K093537 \| ESW Priscilla Chung [M.I.Tech Co., Ltd.]	HANAROSTENT? Esophagus (CCC)	2010-06-28
PMN K093537 \| ESW M.I.Tech Co., Ltd.	HANAROSTENT? Esophagus (CCC)	2010-06-28
PMN K093537 M.I. TECH CO., LTD.	HANAROSTENT ESOPHAGUS (CCC)	2010-06-04
PMN K072094 M.I. TECH CO., LTD.	CHOOSTENT	2008-09-25

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NCAGE Code	1X40F	M.I.TECH CO., LTD.
CAGE Code	1X40F	M.I.TECH CO., LTD.