BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    EXSYS DEXi (EXSYS DEXi-A402S-FRM)

    Reg #: 3035495273 · FEI: 3035495273 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ECORAY CO.,LTD.
    Registration Number
    3035495273
    FEI Number
    3035495273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    60-10, Nanosandan 5-ro, Nam-myeon,
    City
    Jangseong-gun, Jeollanam-do, Jeonnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K233530

    Owner / Operator

    Firm Name
    EcoRay Co.,Ltd.
    Operator Number
    10092395
    Address
    60-10, Nanosandan 5-ro, Nam-myeon,
    City
    Jangseong-gun, Jeollanam-do,
    State
    Jeonnam
    Postal Code
    57248
    Country
    KR
    Correspondent
    Young pyo Kim

    Products

    Device Name Product Code
    System, X-Ray, Stationary KPR

    Proprietary Names

    EXSYS DEXi (EXSYS DEXi-A402S-FRM) EXSYS DEXi (EXSYS DEXi-A503T-FRM) EXSYS DEXi (EXSYS DEXi-A401S-FRM) EXSYS DEXi (EXSYS DEXi-D401P-FRM) EXSYS DEXi (EXSYS DEXi-A401P-FRM) EXSYS DEXi (EXSYS DEXi-D402S-FRM) EXSYS DEXi (EXSYS DEXi-D401S-FRM) EXSYS DEXi (EXSYS DEXi-A402P-FRM) EXSYS DEXi (EXSYS DEXi-D402P-FRM) EXSYS DEXi (EXSYS DEXi-D503T-FRM)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)