Alpinion Medical Systems Co L T D

FDA Filings

This page includes the latest FDA filings for Alpinion Medical Systems 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: 3008950127
• FEI Number: 3008950127
• Name: ALPINION MEDICAL SYSTEMS Co., Ltd.
• Owner & Operator: Alpinion Medical Systems Co., Ltd.
• Contact Address: 5FL,I Dong,77,Heungan-daero 81beon-gil,D Anyang-si,; Gyeonggi-do KR-NOTA 14117 KR
• Official Correspondent:
  • Kyoungmin PARK
  • 82-70-7465-2070
• US Agent:
  • KEVIN CHUN
  • ALPINION USA
  • 425 9491059
  • 425 9494910
  • kevin.chun@alpinionusa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5FL, I Dong ,77, Heungan-daero 81beon-gil Dongan-gu, Anyang-si,; Gyeonggi-do, 14117 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800013545008 Alpinion Medical Systems Co., Ltd.	X-CUBE 60	2022-11-16
GUDID 08800013544001 Alpinion Medical Systems Co., Ltd.	X-CUBE 50	2022-11-16
GUDID 08800013531001 Alpinion Medical Systems Co., Ltd.	minisono	2022-11-16
GUDID 08800013530004 Alpinion Medical Systems Co., Ltd.	minisono	2022-11-16
GUDID 08800013528001 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013527004 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013526007 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013525000 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013524003 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013523006 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013522009 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013521002 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013520005 Alpinion Medical Systems Co., Ltd.	E-CUBE	2022-11-16
GUDID 08800013519009 Alpinion Medical Systems Co., Ltd.	TEE3-7	2022-11-16
GUDID 08800013514035 Alpinion Medical Systems Co., Ltd.	VC1-6T	2022-11-16
GUDID 08800013514028 Alpinion Medical Systems Co., Ltd.	SVC1-6H	2022-11-16
GUDID 08800013514011 Alpinion Medical Systems Co., Ltd.	VC1-6	2022-11-16
GUDID 08800013514004 Alpinion Medical Systems Co., Ltd.	SVC1-6	2022-11-16
GUDID 08800013513106 Alpinion Medical Systems Co., Ltd.	EC3-10X	2022-11-16
GUDID 08800013513090 Alpinion Medical Systems Co., Ltd.	EV3-10X	2022-11-16
GUDID 08800013513069 Alpinion Medical Systems Co., Ltd.	EC3-10H	2022-11-16
GUDID 08800013513052 Alpinion Medical Systems Co., Ltd.	EV3-10H	2022-11-16
GUDID 08800013513045 Alpinion Medical Systems Co., Ltd.	EV3-10	2022-11-16
GUDID 08800013513038 Alpinion Medical Systems Co., Ltd.	EC3-10	2022-11-16
GUDID 08800013513021 Alpinion Medical Systems Co., Ltd.	E3-10H	2022-11-16
GUDID 08800013513014 Alpinion Medical Systems Co., Ltd.	EN3-10	2022-11-16
GUDID 08800013513007 Alpinion Medical Systems Co., Ltd.	E3-10	2022-11-16
GUDID 08800013512079 Alpinion Medical Systems Co., Ltd.	SP1-5T	2022-11-16
GUDID 08800013512062 Alpinion Medical Systems Co., Ltd.	SP3-8T	2022-11-16
GUDID 08800013512055 Alpinion Medical Systems Co., Ltd.	MP1-5X	2022-11-16
GUDID 08800013512048 Alpinion Medical Systems Co., Ltd.	SPN1-5X	2022-11-16
GUDID 08800013512031 Alpinion Medical Systems Co., Ltd.	SP1-5X	2022-11-16
GUDID 08800013512024 Alpinion Medical Systems Co., Ltd.	SP1-5i	2022-11-16
GUDID 08800013512017 Alpinion Medical Systems Co., Ltd.	SP3-8	2022-11-16
GUDID 08800013512000 Alpinion Medical Systems Co., Ltd.	SP1-5	2022-11-16
GUDID 08800013511119 Alpinion Medical Systems Co., Ltd.	C1-6CT	2022-11-16
GUDID 08800013511102 Alpinion Medical Systems Co., Ltd.	C5-8NT	2022-11-16
GUDID 08800013511089 Alpinion Medical Systems Co., Ltd.	C5-8N	2022-11-16
GUDID 08800013511072 Alpinion Medical Systems Co., Ltd.	C1-6T	2022-11-16
GUDID 08800013511065 Alpinion Medical Systems Co., Ltd.	C5-8	2022-11-16
GUDID 08800013511058 Alpinion Medical Systems Co., Ltd.	SC1-4HS	2022-11-16
GUDID 08800013511041 Alpinion Medical Systems Co., Ltd.	SC1-4H	2022-11-16
GUDID 08800013511034 Alpinion Medical Systems Co., Ltd.	C1-6i	2022-11-16
GUDID 08800013511027 Alpinion Medical Systems Co., Ltd.	SC1-6H	2022-11-16
GUDID 08800013511010 Alpinion Medical Systems Co., Ltd.	C1-6	2022-11-16
GUDID 08800013511003 Alpinion Medical Systems Co., Ltd.	SC1-6	2022-11-16
GUDID 08800013510143 Alpinion Medical Systems Co., Ltd.	IO8-17T	2022-11-16
GUDID 08800013510136 Alpinion Medical Systems Co., Ltd.	IO8-17	2022-11-16
GUDID 08800013510129 Alpinion Medical Systems Co., Ltd.	L3-12T	2022-11-16
GUDID 08800013510105 Alpinion Medical Systems Co., Ltd.	L8-17	2022-11-16
GUDID 08800013510099 Alpinion Medical Systems Co., Ltd.	IO3-12	2022-11-16
GUDID 08800013510082 Alpinion Medical Systems Co., Ltd.	L8-17i	2022-11-16
GUDID 08800013510068 Alpinion Medical Systems Co., Ltd.	L8-17X	2022-11-16
GUDID 08800013510051 Alpinion Medical Systems Co., Ltd.	L3-8i	2022-11-16
GUDID 08800013510044 Alpinion Medical Systems Co., Ltd.	L3-12i	2022-11-16
GUDID 08800013510020 Alpinion Medical Systems Co., Ltd.	L3-8	2022-11-16
GUDID 08800013510013 Alpinion Medical Systems Co., Ltd.	L3-12H	2022-11-16
GUDID 08800013510006 Alpinion Medical Systems Co., Ltd.	L3-12	2022-11-16
GUDID 08800013519023 ALPINION MEDICAL SYSTEMS CO.,LTD	CW2.0	2022-11-02
GUDID 08800013519016 ALPINION MEDICAL SYSTEMS CO.,LTD	CW5.0	2022-11-02
GUDID 08800013515001 ALPINION MEDICAL SYSTEMS CO.,LTD	VE3-10H	2022-11-02
GUDID 08800013513083 ALPINION MEDICAL SYSTEMS CO.,LTD	EV3-10T	2022-11-02
GUDID 08800013513076 ALPINION MEDICAL SYSTEMS CO.,LTD	EC3-10T	2022-11-02
GUDID 08800013512093 ALPINION MEDICAL SYSTEMS CO.,LTD	P1-5CT	2022-11-02
GUDID 08800013510150 ALPINION MEDICAL SYSTEMS CO.,LTD	L3-8H	2022-11-02
GUDID 08800013510075 ALPINION MEDICAL SYSTEMS CO.,LTD	L3-12X	2022-11-02
GUDID 08800013510037 ALPINION MEDICAL SYSTEMS CO.,LTD	L3-12HWD	2022-11-02
PMN K221093 Alpinion Medical Systems Co., Ltd.	X-CUBE 70, X-CUBE 90	2022-10-14
PMN K220857 Alpinion Medical Systems Co., Ltd.	X-CUBE 50, X-CUBE 60	2022-10-13
GUDID 08800013511171 ALPINION MEDICAL SYSTEMS CO.,LTD	C1-6C	2022-07-25
GUDID 08800013543004 ALPINION MEDICAL SYSTEMS CO.,LTD	X-CUBE i9	2022-02-14
GUDID 08800013542007 ALPINION MEDICAL SYSTEMS CO.,LTD	X-CUBE i8	2022-02-14
GUDID 08800013511164 ALPINION MEDICAL SYSTEMS CO.,LTD	C1-7GT	2022-02-14
PMN K213523 Alpinion Medical Systems Co., Ltd.	X-CUBE I8, X-CUBE I9	2022-01-28
GUDID 08800013511157 ALPINION MEDICAL SYSTEMS CO.,LTD	SC2-11H	2021-08-20
GUDID 08800013510211 ALPINION MEDICAL SYSTEMS CO.,LTD	SL3-19X	2021-08-20
GUDID 08800013510174 ALPINION MEDICAL SYSTEMS CO.,LTD	L3-15H	2021-08-20
PMN K211299 Alpinion Medical Systems Co., Ltd.	X-CUBE 70	2021-08-09
GUDID 08800013541000 ALPINION MEDICAL SYSTEMS CO.,LTD	X-CUBE 90	2020-07-23
GUDID 08800013540003 ALPINION MEDICAL SYSTEMS CO.,LTD	X-CUBE 70	2020-07-23
GUDID 08800013519047 ALPINION MEDICAL SYSTEMS CO.,LTD	CW8.0	2020-07-23
GUDID 08800013514042 ALPINION MEDICAL SYSTEMS CO.,LTD	SVC1-8H	2020-07-23
GUDID 08800013513120 ALPINION MEDICAL SYSTEMS CO.,LTD	EV2-11H	2020-07-23
GUDID 08800013513113 ALPINION MEDICAL SYSTEMS CO.,LTD	EC2-11H	2020-07-23
GUDID 08800013512109 ALPINION MEDICAL SYSTEMS CO.,LTD	SP4-12	2020-07-23
GUDID 08800013511140 ALPINION MEDICAL SYSTEMS CO.,LTD	SC2-9H	2020-07-23
GUDID 08800013511126 ALPINION MEDICAL SYSTEMS CO.,LTD	SC1-7H	2020-07-23
GUDID 08800013510204 ALPINION MEDICAL SYSTEMS CO.,LTD	IO7-18	2020-07-23
GUDID 08800013510198 ALPINION MEDICAL SYSTEMS CO.,LTD	SL3-19H	2020-07-23
GUDID 08800013510181 ALPINION MEDICAL SYSTEMS CO.,LTD	L10-25H	2020-07-23
PMN K200450 Alpinion Medical Systems Co., Ltd.	X-Cube 70	2020-07-10
PMN K200449 Alpinion Medical Systems Co., Ltd.	X-Cube 90	2020-07-10
PMN K182594 Alpinion Medical Systems Co., Ltd.	E-CUBE I7	2019-01-24
PMN K182594 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE i7	2019-01-24
PMN K182594 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE i7	2019-01-24
PMN K182594 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE i7	2019-01-24
PMN K182845 Alpinion Medical Systems Co., Ltd.	Minisono	2018-12-27
PMN K182845 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	minisono	2018-12-27
PMN K182845 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	minisono	2018-12-27
PMN K182845 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	minisono	2018-12-27
PMN K181617 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE 8	2018-10-12
PMN K181617 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE 8	2018-10-12
PMN K181617 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE 8	2018-10-12
PMN K181277 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE 12	2018-10-12
PMN K181277 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE 12	2018-10-12
PMN K181277 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE 12	2018-10-12
PMN K181617 Alpinion Medical Systems Co., Ltd.	E-CUBE 8	2018-10-11
PMN K181277 Alpinion Medical Systems Co., Ltd.	E-CUBE 12	2018-09-28
PMN K172732 ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE 8	2017-12-14
PMN K172732 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE8	2017-12-14
PMN K172732 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE8	2017-12-14
PMN K172732 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE8	2017-12-14
PMN K161439 ALPINION MEDICAL SYSTEMS CO., LTD.	E-CUBE 11	2016-09-21
PMN K161439 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE11	2016-09-21
PMN K161439 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE11	2016-09-21
PMN K161439 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE11	2016-09-21
PMN K153424 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBEi7	2016-03-01
PMN K153424 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBEi7	2016-03-01
PMN K153424 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBEi7	2016-03-01
PMN K153424 ALPINION MEDICAL SYSTEMS CO., LTD.	E-CUBE I7	2016-02-26
PMN K150773 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 15 Diagnostic Ultrasound System	2015-07-23
PMN K150773 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2015-07-23
PMN K150773 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2015-07-23
PMN K150773 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2015-07-23
PMN K142884 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE12	2014-12-10
PMN K142884 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE12	2014-12-10
PMN K142884 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE12	2014-12-10
PMN K142733 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE5	2014-11-28
PMN K142733 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE5	2014-11-28
PMN K142733 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE5	2014-11-28
PMN K142884 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 12	2014-10-28
PMN K142733 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 5	2014-10-28
PMN K132687 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2013-12-23
PMN K132687 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2013-12-23
PMN K132687 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2013-12-23
PMN K132687 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 7	2013-11-27
PMN K123610 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2013-02-15
PMN K123610 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2013-02-15
PMN K123610 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2013-02-15
PMN K123610 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 15	2013-02-01
PMN K123611 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2013-01-09
PMN K123611 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2013-01-09
PMN K123611 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2013-01-09
PMN K121888 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2013-01-08
PMN K121888 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2013-01-08
PMN K121888 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE15	2013-01-08
PMN K123611 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 7	2012-12-21
PMN K121937 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBEINNO	2012-09-24
PMN K121937 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBEINNO	2012-09-24
PMN K121937 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBEINNO	2012-09-24
PMN K121729 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2012-09-24
PMN K121729 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2012-09-24
PMN K121729 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE7	2012-09-24
PMN K120060 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE9	2012-09-24
PMN K120060 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE9	2012-09-24
PMN K120060 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE9	2012-09-24
PMN K121729 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 7	2012-09-20
PMN K121937 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE INNO	2012-07-26
PMN K121888 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 15	2012-07-26
PMN K120060 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 9	2012-03-16
PMN K111864 | IYO ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE9	2011-07-18
PMN K111864 | IYN ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE9	2011-07-18
PMN K111864 | ITX ALPINION MEDICAL SYSTEMS Co., Ltd.	E-CUBE9	2011-07-18
PMN K111864 ALPINION MEDICAL SYSTEMS CO., LTD	E-CUBE 9	2011-07-15

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091063681	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	ULTRASOUND SCANNER	2 CTN
2020090552463	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	ULTRASOUND SCANNER	2 CTN
2020090378734	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	ULTRASOUND SCANNER	2 CTN
2020083181778	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	ULTRASOUND SCANNER	2 CTN
2020081066116	Pusan,South Korea -> Seattle, Washington	MEASURING INSTRUMENTS	13 CTN
2020070170769	Pusan,South Korea -> Seattle, Washington	PARTS FOR MEASURING INSTRUMENTS	6 CTN
2020062362010	Pusan,South Korea -> Seattle, Washington	PARTS FOR MEASURING INSTRUMENTS	6 CTN
2020062255273	Pusan,South Korea -> Seattle, Washington	PARTS FOR MEASURING INSTRUMENTS	6 CTN