BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SAMSUNG ELECTRONICS CO., LTD.

    Reg #: 3032116890 · FEI: 3032116890 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    SAMSUNG ELECTRONICS CO., LTD.
    Registration Number
    3032116890
    FEI Number
    3032116890
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1077, Cheonho-daero, Gangdong-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K242651

    Owner / Operator

    Firm Name
    Samsung Electronics Co., Ltd.
    Operator Number
    10043488
    Address
    129, Samsung-ro, Yeongtong-gu
    City
    Suwon-si
    State
    Gyeonggi
    Postal Code
    16677
    Country
    KR
    Correspondent
    Sangkyun Kang

    US Agent

    Business Name
    Samsung HME America, Inc.
    Contact Name
    Ninad Gujar
    Address
    14 Electronics Ave
    City
    Danvers
    State
    MA
    ZIP
    01923
    Country
    US
    Email
    [email protected]
    Phone
    978 5648632

    Products

    Device Name Product Code
    System, X-Ray, Mobile IZL
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Analyzer, Medical Image MYN

    Proprietary Names

    AccE GM85; GM85; GM85 with Lite; GM85 with Prestige: GM85 Elite AccE GM85; GM85; GM85 with Lite; GM85 with Prestige GR40CW; GM85 GC85A GF85 GF85-3P AccE GF85 GF85-SP GM85 GR40CW; S4335-WV ALND; Auto Lung Nodule Detection GR40CW; GM85; GC85A GR40CW; S4335-W; XGEO GR40CW AccE GC85A; GC85A; GC85A with Prestige GR40CW; S3025-W; S4343-W GR40CW; GR40CWC; GR40CWD

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device