FDA Device Entity Profile: Samsung Electronics Co., Ltd.

Known Identifiers & Locations

FEI Numbers 3004938766, 3010300212, 3017616353, 3032116890

Owner Operator Numbers 10043488, 10076996

Locations Covered Danvers, MA, US; Seoul, KR; Suwon-si Gyeonggi, KR

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3004938766	Samsung HME America, Inc.	Danvers, MA, US	Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device	View Details
3010300212	Samsung Electronics Co., Ltd.	Suwon-si Gyeonggi, KR	Manufacture Medical Device	View Details
3017616353	Samsung Electronics Co., Ltd. Mobile eXperience Business	Suwon-si Gyeonggi, KR	Manufacture Medical Device	View Details
3032116890	SAMSUNG ELECTRONICS CO., LTD.	Seoul, KR	Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K123106	DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A	2013-06-20	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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