BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    FCU CO., LTD.

    Reg #: 3017955833 · FEI: 3017955833 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    FCU CO., LTD.
    Registration Number
    3017955833
    FEI Number
    3017955833
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2F, 62-4, Techno 1-ro, Yuseong-gu
    City
    Daejeon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K210468

    Owner / Operator

    Firm Name
    FCU Co., Ltd.
    Operator Number
    10082644
    Address
    2F, 62-4, Techno 1-ro, Yuseong-gu
    City
    Daejeon
    State
    KR-30
    Postal Code
    34014
    Country
    KR
    Correspondent
    Seline Kim

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    SiteRite 9 Cue Probe (SKU 9770803) SC1 AcuViz Pocket

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device