BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    AccE GM85; GM85; GM85 with Lite; GM85 with Prestige: GM85 Elite

    Reg #: 3032116890 · FEI: 3032116890 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SAMSUNG ELECTRONICS CO., LTD.
    Registration Number
    3032116890
    FEI Number
    3032116890
    Status
    Active
    Expiry Year
    2025
    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
    SUBONG BAE

    US Agent

    Business Name
    NEUROLOGICA CORPORATION
    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

    Proprietary Names

    AccE GM85; GM85; GM85 with Lite; GM85 with Prestige: GM85 Elite

    Establishment Types

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