BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Reformat Gateway

    Reg #: 3003989064 · FEI: 3003989064 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INFINITT HEALTHCARE CO., LTD.
    Registration Number
    3003989064
    FEI Number
    3003989064
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12F Daerung Post Tower III, 27 Digital-ro 34-gil, Guro-gu, Seoul, 08378, South Korea
    City
    SEOUL
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K052284

    Owner / Operator

    Firm Name
    INFINITT Healthcare Co., Ltd.
    Operator Number
    9055477
    Address
    12F Daerung Post Tower III, 182-4, Guro-Dong, Guro-Gu
    City
    SEOUL
    State
    KR-NOTA
    Postal Code
    08378
    Country
    KR
    Correspondent
    JinJun - Kim

    US Agent

    Business Name
    David Smarro
    Contact Name
    David Smarro
    Address
    755 Memorial Parkway, Suite 304
    City
    Phillipsburg
    State
    NJ
    ZIP
    08865
    Country
    US
    Email
    [email protected]
    Phone
    908 3876960 ext. 111

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Reformat Gateway

    Establishment Types

    Manufacture Medical Device