BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    X-CUBE i8

    Reg #: 3008950127 · FEI: 3008950127 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    ALPINION MEDICAL SYSTEMS Co., Ltd.
    Registration Number
    3008950127
    FEI Number
    3008950127
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4F, 15, Magokjungang 14-ro
    City
    Gangseo-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K213523

    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
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    X-CUBE i8 X-CUBE i9

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device