Sewoon Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Sewoon 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)

100700

DUNS 687784405

FDA Registration(s)

• Registration Number: 3000247987
• FEI Number: 3000247987
• Name: SEWOON MEDICAL CO., LTD.
• Owner & Operator: SEWOON Medical Co., Ltd.
• Contact Address: 60 Dorim-gil, Ipjang-myeon, Seobuk-gu ; Cheonan-si KR-44 Chungcheongnamdo 31061 KR
• Official Correspondent:
  • Jaehee Lee
  • 82-10-33601526-776
• US Agent:
  • Soojung Moon
  • Allura Medical Solution Inc.
  • 407 2429796
  • 210 8990070
  • sjmoon@allurameds.com
• Importing Logistics Registration:
  • Importer: THORACENT, INC
  • Address: 11 Stewart Ave, Unit 1, Ste 200 ; Huntington, NY 11743 UNITED STATES
  • Email Address: brian@thoracent.com
  • Phone: 1 917 4396742
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 60, Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do,; SEOUL Seoul Teugbyeolsi, 31061 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08806369498685 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369477864 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369455008 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369454582 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369454568 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369454544 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369454520 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369454506 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369454025 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369454001 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PS)	2023-08-04
GUDID 08806369453646 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453622 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453585 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453561 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453547 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453509 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453103 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453080 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453066 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453042 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453028 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369453004 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452649 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452625 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452601 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452588 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452564 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452526 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452120 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452106 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452083 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452069 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452045 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452021 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369452007 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369427777 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-04
GUDID 08806369427739 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-04
GUDID 08806369427692 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-04
GUDID 08806369427654 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-04
GUDID 08806369427616 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-04
GUDID 08806369427494 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369427456 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369427418 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369427371 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369427333 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369400244 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369400220 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(SS)	2023-08-04
GUDID 08806369498722 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-03
GUDID 08806369498708 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-03
GUDID 08806369456500 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-03
GUDID 08806369456104 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-03
GUDID 08806369456081 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-03
GUDID 08806369456043 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-03
GUDID 08806369456029 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-03
GUDID 08806369455503 Sewoon Medical Co., Ltd.	BAROVAC® Evacuator Closed Wound Drainage System(PP)	2023-08-03
GUDID 08806369403801 Sewoon Medical Co., Ltd.	TEMPERATURE SENSING FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403788 Sewoon Medical Co., Ltd.	TEMPERATURE SENSING FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403764 Sewoon Medical Co., Ltd.	TEMPERATURE SENSING FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403740 Sewoon Medical Co., Ltd.	TEMPERATURE SENSING FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403726 Sewoon Medical Co., Ltd.	TEMPERATURE SENSING FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403702 Sewoon Medical Co., Ltd.	TEMPERATURE SENSING FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403603 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403108 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403085 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403061 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403047 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403023 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369403009 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369402620 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369402606 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369402583 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369402569 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369402545 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369402521 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369402507 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369402002 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369400626 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369400602 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369400589 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369400565 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369400541 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369400527 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369400503 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369400008 Sewoon Medical Co., Ltd.	ALL SILICONE FOLEY BALLOON CATHETER	2023-08-01
GUDID 08806369422932 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422918 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422895 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422871 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422857 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422833 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422819 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422796 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422772 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369422758 Sewoon Medical Co., Ltd.	BONASTENT® Tracheal/Bronchial	2021-11-01
GUDID 08806369458603 Sewoon Medical Co., Ltd.	BONASTENT® Esophageal	2021-10-25
GUDID 08806369458580 Sewoon Medical Co., Ltd.	BONASTENT® Esophageal	2021-10-25
GUDID 08806369458566 Sewoon Medical Co., Ltd.	BONASTENT® Esophageal	2021-10-25
GUDID 08806369458542 Sewoon Medical Co., Ltd.	BONASTENT® Esophageal	2021-10-25
GUDID 08806369458528 Sewoon Medical Co., Ltd.	BONASTENT® Esophageal	2021-10-25
GUDID 08806369458504 Sewoon Medical Co., Ltd.	BONASTENT® Esophageal	2021-10-25
PMN K140760 | FGE SEWOON MEDICAL CO., LTD.	Bonastent	2016-07-25
PMN K140472 | JCT SEWOON MEDICAL CO., LTD.	Bonastent	2016-07-25
PMN K093003 | FGE SEWOON MEDICAL CO., LTD.	Bonastent	2012-05-10
PMN K092144 | ESW SEWOON MEDICAL CO., LTD.	Bonastent	2012-05-10
JAY SEWOON MEDICAL CO., LTD.	Barovac	2008-12-04
PMN K022287 | EZL SEWOON MEDICAL CO., LTD.	Temp Foley	2008-01-16
PMN K013276 | EZL SEWOON MEDICAL CO., LTD.	Barovac	2005-11-03
PMN K013276 SEWOON MEDICAL CO., LTD.	ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)	2002-02-15
JOL SEWOON MEDICAL CO., LTD.	Barovac	1999-01-08
FON SEWOON MEDICAL CO., LTD.	Barovac	1999-01-08
FCN SEWOON MEDICAL CO., LTD.	Barovac	1999-01-08
BSR SEWOON MEDICAL CO., LTD.	Barovac	1999-01-08

Related Finance Registrations

NCAGE Code	1478F	SEWOON MEDICAL CO., LTD.
CAGE Code	1478F	SEWOON MEDICAL CO., LTD.