BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    OTOM Co., Ltd.

    Reg #: 3015537309 · FEI: 3015537309 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    OTOM Co., Ltd.
    Registration Number
    3015537309
    FEI Number
    3015537309
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2F, 29, 880 bungil, Woochi-ro, Buk-gu
    City
    Gwangju
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K213405

    Owner / Operator

    Firm Name
    OTOM Co., Ltd.
    Operator Number
    10060836
    Address
    2F, 29, 880 bungil, Woochi-ro, Buk-gu
    City
    Gwangju
    State
    KR-29
    Postal Code
    61042
    Country
    KR

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St. Suite 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    System, X-Ray, Mobile IZL

    Proprietary Names

    MINE ALNU

    Establishment Types

    Manufacture Medical Device