BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Single use Needle/Sofjec, CarePoint Precision

    Reg #: 3030089798 · FEI: 3030089798 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HLB LIFE SCIENCE CO., LTD.
    Registration Number
    3030089798
    FEI Number
    3030089798
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    122-39, Gieopdanji-ro, Gongdo-eup
    City
    Anseong-si, Gyeonggi-do
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K241856

    Owner / Operator

    Firm Name
    HLB Life Science Co., Ltd.
    Operator Number
    10089317
    Address
    122-39, Gieopdanji-ro, Gongdo-eup
    City
    Anseong-si, Gyeonggi-do
    State
    KR-NOTA
    Postal Code
    17551
    Country
    KR

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Single use Needle/Sofjec, CarePoint Precision Membrane Filter Syringe/Sofjec, CarePoint Precision Single use Syringe with/without Needle/Sofjec, CarePoint Precision

    Establishment Types

    Manufacture Medical Device