BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ALPINION MEDICAL SYSTEMS CO., LTD.

    Reg #: 3024838922 · FEI: 3024838922 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    72
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ALPINION MEDICAL SYSTEMS CO., LTD.
    Registration Number
    3024838922
    FEI Number
    3024838922
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4F, 16, Simin-daero 327beon-gil, Dongan-gu
    City
    Anyang-si Gyeonggi
    Country
    KR

    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
    Gene Kim
    Address
    21222 30th Dr Se Ste C-122
    City
    Bothell
    State
    WA
    ZIP
    98021
    Country
    US
    Email
    [email protected]
    Phone
    425 9494901

    Products

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

    Proprietary Names

    EC2-11H C5-8NT L10-25H SC2-11H MP1-5X L3-15H TEE3-7 L3-8H X-CUBE 90 IO7-18 EV2-11H X-CUBE 70 SC1-7H SP3-8T VE3-10H L3-12X CW2 SL3-19H CW5 SP4-12 SL3-19X SC2-9H CW8 SVC1-8H X-CUBE 60 X-CUBE 50 EC3-10T EV3-10T C1-7GT P1-5CT L3-12HWD E-CUBE 5 L3-12T C1-6T minisono C1-6 minisono L3-12 SC1-4H SC1-6H E-CUBE 15 L3-12H L8-17X SP1-5X E3-10H C1-6CT X-CUBE i9 X-CUBE i8 C1-6C VC1-6T L8-17H IO3-12 SC1-4HS L3-8 EV3-10H C5-8N C5-8 SPN1-5X SVC1-6 EV3-10X SVC1-6H SP3-8 IO8-17 EC3-10X EC3-10H E-CUBE i7 IO8-17T SP1-5T E-CUBE 8 E3-10 E-CUBE 12 SC1-6 L3-12 SP1-5

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)