BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Samsung HME America, Inc.

    Reg #: 3004938766 · FEI: 3004938766 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Samsung HME America, Inc.
    Registration Number
    3004938766
    FEI Number
    3004938766
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14 Electronics Ave
    City
    Danvers
    State
    MA
    ZIP
    01923
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211711

    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

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK

    Proprietary Names

    OmniTom Elite BodyTom 64 OmniTom Elite with PCD BodyTom Elite VetTom 32 CereTom Elite VetTom 8

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device