BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SOOIL DEVELOPMENT CO., LTD.

    Reg #: 9616814 · FEI: 3003024060 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SOOIL DEVELOPMENT CO., LTD.
    Registration Number
    9616814
    FEI Number
    3003024060
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    62, Yonggu-daero 2325beon-gil, Giheung-gu
    City
    Yongin-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K022317

    Owner / Operator

    Firm Name
    SOOIL DEVELOPMENT CO., LTD.
    Operator Number
    9041551
    Address
    62, Yonggu-daero 2325beon-gil, Giheung-gu
    City
    Yongin-si
    State
    Gyeonggi
    Postal Code
    16922
    Country
    KR

    US Agent

    Business Name
    SOOIL LLC
    Contact Name
    Jong Hyun Kim
    Address
    9919 Hibert Street, Suite C
    City
    San Diego
    State
    CA
    ZIP
    92131
    Country
    US
    Email
    [email protected]
    Phone
    858 4040741

    Products

    Device Name Product Code
    Pump, Infusion, Insulin LZG
    Accessories, Pump, Infusion MRZ

    Proprietary Names

    DANA DIABECARE II INSULIN PUMP DANA DIABECARE INSULIN PUMP DANA DIABECARE IIS DANA 3CC SYRINGE INSULIN RESERVOIR

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device