Sejong Medical Co L T D

FDA Filings

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

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

258830

DUNS 689850476

FDA Registration(s)

Registration Number	3011194193
FEI Number	3011194193
Name	Michael Van de Woude
Owner & Operator	Sejong Medical Co., Ltd.
Contact Address	11, Sinchon 2-ro Paju-si KR-41 Gyeonggido 10880 KR
US Agent	Michael Van de Woude Emergo Global Representation, LLC 512 3279997 512 3279998 usagent@ul.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K200639 Sejong Medical Co., Ltd.	LAP-iX	2021-09-29
PMN K200638 Sejong Medical Co., Ltd.	LAP-iX Suction Irrigation	2020-04-03
GUDID 88806182210873 Sejong Medical Co., Ltd	Laport N20-0510	2020-01-09
GUDID 88806182210583 Sejong Medical Co., Ltd	Laport N23-1210	2020-01-09
GUDID 88806182210514 Sejong Medical Co., Ltd	Laport N23-0575	2020-01-09
GUDID 88806182210392 Sejong Medical Co., Ltd	Laport N21-0575	2020-01-09
GUDID 88806182210378 Sejong Medical Co., Ltd	Laport N21-0510	2020-01-09
GUDID 88806182210330 Sejong Medical Co., Ltd	Laport N22-0510	2020-01-09
GUDID 08806182210433 Sejong Medical Co., Ltd	Laport N21-1110	2020-01-09
PMN K173108 \| FYD Michael Van de Woude [Sejong Medical Co., Ltd.]	Smoklean Single use smoke filter	2018-08-14
PMN K173108 Sejong Medical Co., Ltd.	Smoklean	2018-05-18
PMN K173112 \| GEI Michael Van de Woude [Sejong Medical Co., Ltd.]	LAP-iX	2018-02-22
PMN K173111 \| HET Michael Van de Woude [Sejong Medical Co., Ltd.]	LAP-iX Suction Irrigation	2018-02-22
PMN K171741 \| GCJ Michael Van de Woude [Sejong Medical Co., Ltd.]	Laport	2018-02-22
PMN K171726 \| GCJ Michael Van de Woude [Sejong Medical Co., Ltd.]	LapBag	2018-02-22
PMN K173111 Sejong Medical Co., Ltd.	LAP-iX Suction Irrigation	2017-11-28
PMN K173112 Sejong Medical Co., Ltd.	LAP-iX	2017-11-21
PMN K171726 Sejong Medical Co., Ltd.	LapBag	2017-09-25
PMN K171741 Sejong Medical Co., Ltd.	Laport	2017-08-29

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202001149362	Pusan,South Korea -> San Juan, Puerto Rico	LAPAROSCOPIC SURGERY DEVICES	23 CTN
201905132638	Panama Canal - Caribbean,Panama -> San Juan, Puerto Rico	LAPAROSCOPIC SURGERY DEVICES	144 CTN
2019031150983	Panama Canal - Caribbean,Panama -> San Juan, Puerto Rico	LAPAROSCOPIC SURGERY DEVICES	5680 PCS