Sg Healthcare Co L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3011665470
• FEI Number: 3011665470
• Name: SG Healthcare, Inc.
• Owner & Operator: SG Healthcare Co. Ltd
• Contact Address: 10, Yangnyeong-ro ; Moga-myeon, Icheon-si KR-41 Gyeonggido 17408 KR
• Official Correspondent:
  • Rosa Ku
  • 82-31-7900647-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4801 Wilshire Blvd Ste 104 ; Los Angeles, CA 90010 US

• Registration Number: 3009715136
• FEI Number: 3009715136
• Name: SG HEALTHCARE CO LTD
• Owner & Operator: SG Healthcare Co. Ltd
• Contact Address: 10, Yangnyeong-ro ; Moga-myeon, Icheon-si KR-41 Gyeonggido 17408 KR
• Official Correspondent:
  • Rosa Ku
  • 82-31-7900647-x
• US Agent:
  • Daniel Kamm
  • Kamm & Associates
  • 239 4171727
  • fda.help.now@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10, Yangnyeong-ro ; Moga-myeon, Icheon-si Gyeonggido, 17408 KR
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K222080 SG Healthcare CO LTD	Garion Image-Intensified Fluoroscopic X-Ray System, Mobile	2022-10-06
IZO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	ZR75PN80	2018-08-14
IZO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	ZR75PN65	2018-08-14
IZO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	ZR75PN50	2018-08-14
IZO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	ZR75PN40	2018-08-14
IZO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	ZR75PN32	2018-08-14
PMN K032628 | IZL SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	PXP-15/20/40HF	2018-07-09
PMN K170480 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong Retro 4343A	2018-05-16
PMN K170480 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	JUMONG RETRO	2018-05-16
PMN K002685 | IZL SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong Mobile	2017-09-19
PMN K091918 | OXO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	GARION	2017-04-07
PMN K091918 | OWB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	GARION	2017-04-07
PMN K091918 | JAA SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	GARION	2017-04-07
IZZ SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong M	2016-08-03
PMN K122173 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	JUMONG RETRO	2015-11-07
PMN K122173 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Garion	2015-11-07
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong V	2015-05-13
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong U	2015-05-13
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong S	2015-05-13
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong M	2015-05-13
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong General	2015-05-13
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong F	2015-05-13
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong E	2015-05-13
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong C	2015-05-13
PMN K150816 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	EVA HF 525	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong V	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong U	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong S	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong M	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong General	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong F	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong E	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Jumong C	2015-05-13
PMN K150816 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	EVA HF 525	2015-05-13
PMN K150816 SG HEALTHCARE CO LTD	Jumong Series	2015-05-08
PMN K130801 | IYO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	G5	2014-11-29
PMN K130801 | IYN SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	G5	2014-11-29
PMN K130801 | ITX SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	G5	2014-11-29
PMN K071401 | MQB SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	JUMONG	2014-10-30
PMN K071401 | KPR SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	JUMONG	2014-10-30
PMN K082100 | LNH SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	Invictus 1.5	2014-09-26
PMN K102023 | IYO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	G10	2014-08-29
PMN K102023 | IYN SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	G10	2014-08-29
PMN K102023 | ITX SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	G10	2014-08-29
PMN K061488 | IYO SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	T6	2014-08-29
PMN K061488 | IYN SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	T6	2014-08-29
PMN K061488 | ITX SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	T6	2014-08-29
PMN K110942 | LNH SG HEALTHCARE CO LTD [SG Healthcare Co. Ltd]	INVICTUS	2014-06-11

Related Finance Registrations

NCAGE Code	3S92F	SG HEALTHCARE CO.,LTD
CAGE Code	3S92F	SG HEALTHCARE CO.,LTD INTERNATIONAL SALES
S.A.M. Registration	3S92F [688442900]	SG HEALTHCARE CO., LTD.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080756630	Pusan,South Korea -> Long Beach, California	X-RAY EQUIPMENTS 9022.14-1090	1 PKG
2020042543024	Pusan,South Korea -> Long Beach, California	X-RAY EQUIPMENTS 9022.14-1090	5 PKG
2019080322143	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	X-RAY EQUIPMENTS	3 PKG
2019011574993	Pusan,South Korea -> Los Angeles, California	BLING POP MASK	1 PKG
2018110853695	Pusan,South Korea -> Los Angeles, California	DIGITAL RADIOGRAPHY SYSTEM	5 PKG
2018110164031	Pusan,South Korea -> Los Angeles, California	DIGITAL RADIOGRAPHY SYSTEM	15 PKG
2018092722156	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	X-RAY MACHINE	1 PKG