Samsung Electronics Co L T D

FDA Filings

This page includes the latest FDA filings for Samsung Electronics 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: 3010300212
• FEI Number: 3010300212
• Name: Samsung Electronics Co., Ltd.
• Owner & Operator: Samsung Electronics Co., Ltd.
• Contact Address: 129, Samsung-ro, Yeongtong-gu ; Suwon-si KR-41 Gyeonggido 443-742 KR
• Official Correspondent:
  • ChulSin Kim
  • 82-31-2007661-x
• US Agent:
  • Ninad Gujar
  • NEUROLOGICA CORPORATION
  • 978 5648632
  • ngujar@neurologica.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 129, Samsung-ro, Yeongtong-gu ; Suwon-si Gyeonggido, 16677 KR
• Establishment Type: Manufacture Medical Device

• Registration Number: 3004938766
• FEI Number: 3004938766
• Name: NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS)
• Owner & Operator: Samsung Electronics Co., Ltd.
• Contact Address: 129, Samsung-ro, Yeongtong-gu ; Suwon-si KR-41 Gyeonggido 443-742 KR
• Official Correspondent:
  • ChulSin Kim
  • 82-31-2007661-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 14 ELECTRONICS AVENUE ; Danvers, MA 01923 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 08806094948240 Samsung Electronics Co., Ltd.	Samsung ECG Monitor App with Irregular Heart Rhythm Notification	2023-10-31
GUDID 08806094948233 Samsung Electronics Co., Ltd.	Samsung ECG Monitor App with Irregular Heart Rhythm Notification	2023-10-31
GUDID 08806094744934 Samsung Electronics Co., Ltd.		2022-10-28
PMN K222353 Samsung Electronics Co., LTD.	GM85	2022-09-29
GUDID 08806094458220 Samsung Electronics Co., Ltd.		2022-05-12
GUDID 08806094458213 Samsung Electronics Co., Ltd.		2022-05-12
PMN K220175 Samsung Electronics Co. Ltd.	GM85	2022-04-21
PMN K213452 Samsung Electronics Co., Ltd.	GEMS-H	2022-04-21
PMN K211139 Samsung Electronics Co., Ltd.	CUBE Air Purifier	2021-11-26
GUDID 08806088670560 Samsung Electronics Co., Ltd.		2021-10-11
GUDID 08806088520971 Samsung Electronics Co., Ltd.		2021-10-11
GUDID 08806088351889 Samsung Electronics Co., Ltd.		2021-10-11
GUDID 08806088351872 Samsung Electronics Co., Ltd.		2021-10-11
GUDID 08806092938854 Samsung Electronics Co., Ltd.	Samsung Health Body Composition	2021-09-15
GUDID 08806092938847 Samsung Electronics Co., Ltd.	Samsung Health Body Composition	2021-09-15
PMN K201560 Samsung Electronics Co.,Ltd.	Auto Lung Nodule Detection	2021-08-31
GUDID 08806090792045 Samsung Electronics Co., Ltd.	Samsung ECG Monitor Application	2020-10-02
GUDID 08806090792021 Samsung Electronics Co., Ltd.	Samsung ECG Monitor Application	2020-10-02
PMN K201168 Samsung Electronics Co., Ltd	ECG Monitor App	2020-08-04
GUDID 08806088773797 Samsung Electronics Co., Ltd.		2019-06-27
GUDID 08801643990107 Samsung Electronics Co., Ltd.		2019-06-27
GUDID 08801643990091 Samsung Electronics Co., Ltd.		2019-06-27
GUDID 08806088512266 Samsung Electronics Co., Ltd.		2019-05-07
GUDID 08806088512211 Samsung Electronics Co., Ltd.		2019-05-07
GUDID 08806086571210 Samsung Electronics Co., Ltd.		2019-05-07
GUDID 08801643431419 Samsung Electronics Co., Ltd.		2019-05-07
PMN K182183 | MQB Samsung Electronics Co., Ltd.	GU60A	2018-12-09
PMN K182183 | MQB Samsung Electronics Co., Ltd.	GU60A-65	2018-12-09
PMN K182183 | MQB Samsung Electronics Co., Ltd.	GR50A	2018-12-09
PMN K182183 | MQB Samsung Electronics Co., Ltd.	GR40CW	2018-12-09
PMN K182183 | MQB Samsung Electronics Co., Ltd.	GM85	2018-12-09
PMN K182183 | MQB Samsung Electronics Co., Ltd.	GF50	2018-12-09
PMN K182183 | MQB Samsung Electronics Co., Ltd.	GC85A	2018-12-09
PMN K182183 | MQB Samsung Electronics Co., Ltd.	GC70	2018-12-09
PMN K182183 | KPR Samsung Electronics Co., Ltd.	GU60A	2018-12-09
PMN K182183 | KPR Samsung Electronics Co., Ltd.	GU60A-65	2018-12-09
PMN K182183 | KPR Samsung Electronics Co., Ltd.	GR50A	2018-12-09
PMN K182183 | KPR Samsung Electronics Co., Ltd.	GR40CW	2018-12-09
PMN K182183 | KPR Samsung Electronics Co., Ltd.	GM85	2018-12-09
PMN K182183 | KPR Samsung Electronics Co., Ltd.	GF50	2018-12-09
PMN K182183 | KPR Samsung Electronics Co., Ltd.	GC85A	2018-12-09
PMN K182183 | KPR Samsung Electronics Co., Ltd.	GC70	2018-12-09
PMN K182183 | IZL Samsung Electronics Co., Ltd.	GU60A	2018-12-09
PMN K182183 | IZL Samsung Electronics Co., Ltd.	GU60A-65	2018-12-09
PMN K182183 | IZL Samsung Electronics Co., Ltd.	GR50A	2018-12-09
PMN K182183 | IZL Samsung Electronics Co., Ltd.	GR40CW	2018-12-09
PMN K182183 | IZL Samsung Electronics Co., Ltd.	GM85	2018-12-09
PMN K182183 | IZL Samsung Electronics Co., Ltd.	GF50	2018-12-09
PMN K182183 | IZL Samsung Electronics Co., Ltd.	GC85A	2018-12-09
PMN K182183 | IZL Samsung Electronics Co., Ltd.	GC70	2018-12-09
PMN K182183 Samsung Electronics Co., LTD.	GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A	2018-12-07
PMN K182647 | KPR Samsung Electronics Co., Ltd.	GC70	2018-10-30
PMN K182622 | KPR Samsung Electronics Co., Ltd.	GU60A	2018-10-30
PMN K182622 | KPR Samsung Electronics Co., Ltd.	GU60A-65	2018-10-30
PMN K182622 | IZL Samsung Electronics Co., Ltd.	GU60A	2018-10-30
PMN K182622 | IZL Samsung Electronics Co., Ltd.	GU60A-65	2018-10-30
PMN K182647 Samsung Electronics Co., Ltd.	GC70	2018-10-24
PMN K182622 SAMSUNG ELECTRONICS CO., LTD.	GU60A, GU60A-65	2018-10-23
PMN K181631 | MQB Samsung Electronics Co., Ltd.	GR40CWD	2018-07-25
PMN K181631 | MQB Samsung Electronics Co., Ltd.	GR40CWC	2018-07-25
PMN K181631 | MQB Samsung Electronics Co., Ltd.	GR40CW	2018-07-25
PMN K181631 | IZL Samsung Electronics Co., Ltd.	GR40CWD	2018-07-25
PMN K181631 | IZL Samsung Electronics Co., Ltd.	GR40CWC	2018-07-25
PMN K181631 | IZL Samsung Electronics Co., Ltd.	GR40CW	2018-07-25
PMN K181629 | KPR Samsung Electronics Co., Ltd.	GC85A	2018-07-25
PMN K181629 | KPR Samsung Electronics Co., Ltd.	GC85A with Prestige	2018-07-25
PMN K181629 | KPR Samsung Electronics Co., Ltd.	AccE GC85A	2018-07-25
PMN K181626 | IZL Samsung Electronics Co., Ltd.	GM85	2018-07-25
PMN K181626 | IZL Samsung Electronics Co., Ltd.	GM85 with Prestige	2018-07-25
PMN K181626 | IZL Samsung Electronics Co., Ltd.	GM85 with Lite	2018-07-25
PMN K181626 | IZL Samsung Electronics Co., Ltd.	AccE GM85	2018-07-25
PMN K181631 Samsung Electronics Co., Ltd.	GR40CW	2018-07-20
PMN K181629 Samsung Electronics Co., Ltd.	GC85A	2018-07-20
PMN K181626 Samsung Electronics Co., Ltd.	Digital Diagnostic Mobile X-ray System	2018-07-20
PMN K180543 Samsung Electronics Co.,Ltd.	GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, And GM85	2018-05-24
PMN K180543 | KPR Samsung Electronics Co., Ltd.	GU60A	2018-05-24
PMN K180543 | KPR Samsung Electronics Co., Ltd.	GU60A-65	2018-05-24
PMN K180543 | KPR Samsung Electronics Co., Ltd.	GR40CW	2018-05-24
PMN K180543 | KPR Samsung Electronics Co., Ltd.	GM85	2018-05-24
PMN K180543 | KPR Samsung Electronics Co., Ltd.	GF50A	2018-05-24
PMN K180543 | KPR Samsung Electronics Co., Ltd.	GF50	2018-05-24
PMN K180543 | KPR Samsung Electronics Co., Ltd.	GC70	2018-05-24
PMN K173828 | KPR Samsung Electronics Co., Ltd.	GU60A	2018-01-17
PMN K173828 | KPR Samsung Electronics Co., Ltd.	GU60A-65	2018-01-17
PMN K173828 | IZL Samsung Electronics Co., Ltd.	GU60A	2018-01-17
PMN K173828 | IZL Samsung Electronics Co., Ltd.	GU60A-65	2018-01-17
PMN K173828 Samsung Electronics Co.,Ltd.	GU60A & GU60A-65	2018-01-12
PMN K172229 | KPR Samsung Electronics Co., Ltd.	GC85A	2017-12-11
PMN K172539 | JAK NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]	CereTom Elite	2017-12-05
PMN K172229 Samsung Electronics Co.,Ltd.	GC85A	2017-11-22
HOT Samsung Electronics Co., Ltd.	Relumino	2017-11-08
PMN K171183 | JAK NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]	OmniTom	2017-08-21
PMN K170238 | JAK NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]	BodyTom Elite	2017-06-22
PMN K171085 | MQB NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]	GMR40	2017-05-24
PMN K171119 | MQB Samsung Electronics Co., Ltd.	GM85	2017-05-15
PMN K171119 | IZL Samsung Electronics Co., Ltd.	GM85	2017-05-15
PMN K171119 Samsung Electronics Co.,Ltd.	GM85	2017-05-12
PMN K163115 | KPR Samsung Electronics Co., Ltd.	GC70	2016-12-08
PMN K163115 SAMSUNG ELECTRONICS CO., LTD.	GC70	2016-12-07
PMN K162278 SAMSUNG ELECTRONICS CO., LTD.	Digital Diagnostic Mobile X-ray System	2016-11-15
PMN K162278 | MQB Samsung Electronics Co., Ltd.	GM85	2016-11-15
PMN K162278 | IZL Samsung Electronics Co., Ltd.	GM85	2016-11-15
PMN K160997 | KPR Samsung Electronics Co., Ltd.	GC85A	2016-07-21
PMN K160997 SAMSUNG ELECTRONICS CO., LTD.	GC85A	2016-07-06
PMN K153401 SAMSUNG ELECTRONICS CO., LTD.	GR40CW	2015-12-21
PMN K153401 | MQB Samsung Electronics Co., Ltd.	S4335-WV	2015-12-21
PMN K153401 | MQB Samsung Electronics Co., Ltd.	GR40CW	2015-12-21
PMN K152094 | MQB Samsung Electronics Co., Ltd.	S4343-W	2015-10-18
PMN K152094 | MQB Samsung Electronics Co., Ltd.	S3025-W	2015-10-18
PMN K152094 | MQB Samsung Electronics Co., Ltd.	GR40CW	2015-10-18
PMN K152094 SAMSUNG ELECTRONICS CO., LTD.	GR40CW	2015-10-16
PMN K142697 | JAK NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]	NExCT 7	2015-07-31
PMN K102677 | JAK NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]	BodyTom	2015-07-31
PMN K090811 | KPS NEUROLOGICA CORPORATION (SUBSIDIARY OF SAMSUNG ELECTRONICS) [Samsung Electronics Co., Ltd.]	InSPira HD	2015-07-31
PMN K151685 | KPR Samsung Electronics Co., Ltd.	GU60A	2015-07-20
PMN K151685 | KPR Samsung Electronics Co., Ltd.	GU60A-65	2015-07-20
PMN K151685 SAMSUNG ELECTRONICS CO., LTD.	GUA60A, GU60A-65	2015-07-17
PMN K151419 SAMSUNG ELECTRONICS CO., LTD.	GF50A	2015-06-23
PMN K151419 | KPR Samsung Electronics Co., Ltd.	GF50A	2015-06-23
PMN K150165 | KPR Samsung Electronics Co., Ltd.	GC85A	2015-04-05
PMN K150165 SAMSUNG ELECTRONICS CO., LTD.	GC85A	2015-04-02
PMN K150097 | IZL Samsung Electronics Co., Ltd.	GM60A	2015-02-22
PMN K150097 | IZL Samsung Electronics Co., Ltd.	GM60A-40S	2015-02-22
PMN K150097 | IZL Samsung Electronics Co., Ltd.	GM60A-32S	2015-02-22
PMN K150097 SAMSUNG ELECTRONICS CO., LTD.	GM60A-32S & GM60A-40S	2015-02-19
PMN K143029 SAMSUNG ELECTRONICS CO., LTD.	Digital Diagnostic X-ray System (GC80)	2015-02-04
PMN K143029 | KPR Samsung Electronics Co., Ltd.	GC80	2015-02-04
PMN K142492 | IZL Samsung Electronics Co., Ltd.	GM60A	2014-12-23
PMN K142492 | IZL Samsung Electronics Co., Ltd.	GM60A-40S	2014-12-23
PMN K142492 | IZL Samsung Electronics Co., Ltd.	GM60A-32S	2014-12-23
PMN K142492 SAMSUNG ELECTRONICS CO., LTD.	GM60A-32S, GM60A-40S	2014-12-17
PMN K140334 | KPR Samsung Electronics Co., Ltd.	XGEO GC80	2014-06-02
PMN K140334 | KPR Samsung Electronics Co., Ltd.	GC80	2014-06-02
PMN K140332 | KPR Samsung Electronics Co., Ltd.	XGEO GU60A	2014-06-02
PMN K140332 | KPR Samsung Electronics Co., Ltd.	GU60A	2014-06-02
PMN K140326 | KPR Samsung Electronics Co., Ltd.	XGEO GF50	2014-06-02
PMN K140326 | KPR Samsung Electronics Co., Ltd.	GF50	2014-06-02
PMN K140235 | MQB Samsung Electronics Co., Ltd.	XGEO GR40CW	2014-06-02
PMN K140235 | MQB Samsung Electronics Co., Ltd.	S4335-W	2014-06-02
PMN K140235 | MQB Samsung Electronics Co., Ltd.	GR40CW	2014-06-02
PMN K140326 SAMSUNG ELECTRONICS CO., LTD.	XGEO GF50	2014-05-29
PMN K140334 SAMSUNG ELECTRONICS CO., LTD.	XGEO GC80	2014-05-28
PMN K140332 SAMSUNG ELECTRONICS CO., LTD.	XGEO GU60A	2014-05-28
PMN K140235 SAMSUNG ELECTRONICS CO., LTD.	XGEO GR40CW	2014-05-15
PMN K132148 SAMSUNG ELECTRONICS CO., LTD.	S HEALTH	2013-12-04
PMN K123106 | KPR Samsung Electronics Co., Ltd.	XGEO GU60A	2013-07-24
PMN K123106 | KPR Samsung Electronics Co., Ltd.	GU60A	2013-07-24
PMN K123105 | KPR Samsung Electronics Co., Ltd.	XGEO GU60	2013-07-24
PMN K123105 | KPR Samsung Electronics Co., Ltd.	GU60	2013-07-24
PMN K123106 SAMSUNG ELECTRONICS CO., LTD.	DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A	2013-06-20
PMN K123105 SAMSUNG ELECTRONICS CO., LTD.	XGEO GU60	2013-06-07
PMN K123098 | KPR Samsung Electronics Co., Ltd.	XGEO GC80	2013-02-20
PMN K123098 | KPR Samsung Electronics Co., Ltd.	GC80	2013-02-20
PMN K123098 SAMSUNG ELECTRONICS CO., LTD.	XGEO GC80	2013-01-18

Related Finance Registrations

NCAGE Code	1542F	SAMSUNG ELECTRONICS CO., LTD.
NCAGE Code	SY213	SAMSUNG ELECTRONICS CO. LTD
NCAGE Code	SP404	SAMSUNG ELECTRONICS CO., LTD.
NCAGE Code	SL929	SAMSUNG ELECTRONICS CO. LTD
CAGE Code	1542F	SAMSUNG ELECTRONICS CO., LTD. MANUFACTURE OF ELECTRIC APPLIANCE & SEMICONDUCTORS
CAGE Code	SL929	SAMSUNG ELECTRONICS CO. LTD
CAGE Code	SP404	SAMSUNG ELECTRONICS CO., LTD.
CAGE Code	SY213	SAMSUNG ELECTRONICS CO. LTD
S.A.M. Registration	1542F [687967554]	SAMSUNG ELECTRONICS CO., LTD. SEC
SEC	0000879316	SAMSUNG ELECTRONICS CO LTD /FI of KOREA, REPUBLIC OF

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092915148	Yantian,China (Mainland) -> Savannah, Georgia	DISHWASHER	158 CTN
2020092915144	Yantian,China (Mainland) -> Savannah, Georgia	DISHWASHER H S CODE 842211 THIS SHIPMENT CONT	158 CTN
2020092915443	Yantian,China (Mainland) -> Tampa, Florida	DISHWASHER H.S CODE :842211 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS NOTIFY PARTY 2: SAMSUNG ELECTRONICS AMERICA INC. 19925 INDEPENDENCE BLVD	158 PCS
2020092915439	Yantian,China (Mainland) -> Tampa, Florida	DISHWASHER H.S CODE :842211 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS FREIGHT PREPAID NOTIFY PARTY 2: SAMSUNG ELECTRONICS AMERICA INC.	158 PCS
2020092915145	Yantian,China (Mainland) -> Savannah, Georgia	DISHWASHER H S CODE 842211 THIS SHIPMENT CONT	158 CTN
2020092915440	Yantian,China (Mainland) -> Tampa, Florida	DISHWASHER H.S CODE :842211 THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS FREIGHT PREPAID NOTIFY PARTY 2: SAMSUNG ELECTRONICS AMERICA INC.	158 PCS
2020092925538	Yantian,China (Mainland) -> Long Beach, California	DISHWASHER - DISHWASHERH.S CODE :842211 SHIPP ER DECLARED THAT: THIS SHIPMENT CONTAINS NO S OLID WOOD PACKING MATERIALS	158 CTN
2020092915142	Yantian,China (Mainland) -> Savannah, Georgia	DISHWASHER	158 CTN