BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ALPINION MEDICAL SYSTEMS Co., Ltd.

    Reg #: 3008950127 · FEI: 3008950127 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    72
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    ALPINION MEDICAL SYSTEMS Co., Ltd.
    Registration Number
    3008950127
    FEI Number
    3008950127
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4F, 15, Magokjungang 14-ro
    City
    Gangseo-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200450

    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

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

    Establishment Types

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