M.I.Tech Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3011458193	3011458193	M.I.Tech Co., Ltd.	1	N	2026-01-01	458, Bongeunsa-ro, Gangnam-gu Seoul KR 06154
3040096051	3040096051	M.I.TECH CO., LTD.	1	N	2026-01-01	17-3 Palbok 1-Gil Deokjin District Jeonju Jeonbuk KR 54883

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
08806367080516	HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent	+821042945040	skim@mitechglobal.com
08806367080547	HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent	+821042945040	skim@mitechglobal.com
08806367080578	HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent	+821042945040	skim@mitechglobal.com
08806367080585	HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent	+821042945040	skim@mitechglobal.com

mitechglobal.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
214810	1951328718	K253327	HANAROSTENT Esophagus Upper (CCC)	ESW	2025-10-30
344797	1951328718	K253327	HANAROSTENT Esophagus Upper (CCC)	ESW	2025-10-30
214810	1869527336	K213251	HANAROSTENT Esophagus Asymmetric (CCC)	ESW	2021-11-18
344797	1869527336	K213251	HANAROSTENT Esophagus Asymmetric (CCC)	ESW	2021-11-18
214810	1205882227	K202973	HANAROSTENT Benefit Biliary (NNN)	FGE	2021-05-11
344797	1205882227	K202973	HANAROSTENT Benefit Biliary (NNN)	FGE	2021-05-11
344797	1315698722	K201342	HANAROSTENT Trachea/Bronchium (CCC)	JCT	2020-12-31
214810	1315698722	K201342	HANAROSTENT Trachea/Bronchium (CCC)	JCT	2020-12-31
214810	1864697460	K201160	HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)	ESW	2021-07-23
344797	1864697460	K201160	HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)	ESW	2021-07-23
344797	1955386892	K200860	HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)	ESW	2020-05-20
214810	1955386892	K200860	HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)	ESW	2020-05-20
214810	1950092319	K190141	HANAROSTENT LowAx Colon/Rectum (NNN)	MQR	2019-03-07
344797	1950092319	K190141	HANAROSTENT LowAx Colon/Rectum (NNN)	MQR	2019-03-07
214810	1860067370	K183616	HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)	MQR	2019-01-10
344797	1860067370	K183616	HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)	MQR	2019-01-10
344797	1576136384	K183396	HANAROSTENT FASTTM Biliary (NNN)	FGE	2019-02-11
214810	1576136384	K183396	HANAROSTENT FASTTM Biliary (NNN)	FGE	2019-02-11
214810	1295398613	K180180	HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)	MQR	2018-11-02
214810	1223795400	K111149	HANAROSTENT BILIARY (NNN)	FGE	2011-12-30
344797	1223795400	K111149	HANAROSTENT BILIARY (NNN)	FGE	2011-12-30
214810	1642076417	K093537	HANAROSTENT ESOPHAGUS (CCC)	ESW	2010-06-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
ESW	9	2025-10-30
FGE	6	2021-05-11
MQR	5	2019-03-07
JCT	2	2020-12-31

PMN#

HANAROSTENT Esophagus Upper (CCC)
2025-10-30
M.I.Tech Co., Ltd.
HANAROSTENT Esophagus Asymmetric (CCC)
2021-11-18
M.I.Tech Co., Ltd.
HANAROSTENT Benefit Biliary (NNN)
2021-05-11
M.I.Tech Co., Ltd.
HANAROSTENT LowAx Colon/Rectum (NNN)
2019-03-07
M.I.Tech Co., Ltd.
HANAROSTENT FASTTM Biliary (NNN)
2019-02-11
M.I.Tech Co., Ltd.
HANAROCare ReJu
2016-07-27
M.I.TECH CO.,LTD

GUDID#

HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-03-11
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-03-11
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-03-11
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-03-11
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-03-11
HANAROSTENT® LowAxTM Colon/Rectum(NNN) - Un-covered self-expanding nitinol colon stent
M.I.Tech Co., Ltd.
2019-03-11
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN) - Un-covered self-expanding nitinol duodenum stent
M.I.Tech Co., Ltd.
2019-02-18
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Trachea/Bronchium(CCC) - Full Covered metallic tracheal stent
M.I.Tech Co., Ltd.
2021-04-30
HANAROSTENT® Biliary (NNN) - Un-covered self-expanding nitinol biliary stent
M.I.Tech Co., Ltd.
2017-07-03

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