BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    X-CUBE 60

    Reg #: 3024838922 · FEI: 3024838922 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ALPINION MEDICAL SYSTEMS CO., LTD.
    Registration Number
    3024838922
    FEI Number
    3024838922
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4F, 16, Simin-daero 327beon-gil, Dongan-gu
    City
    Anyang-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K223564

    Owner / Operator

    Firm Name
    Alpinion Medical Systems Co., Ltd.
    Operator Number
    10037469
    Address
    4F, 15, Magokjungang 14-ro, Gangseo-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    07789
    Country
    KR
    Correspondent
    Bumgi Min

    US Agent

    Business Name
    ALPINION USA
    Contact Name
    Kevin Chun
    Address
    21222 30th Dr SE Ste C-122
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US
    Email
    [email protected]
    Phone
    425 9491059

    Products

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

    Proprietary Names

    X-CUBE 60 X-CUBE 50

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)