BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HLB LIFE SCIENCE CO., LTD.

    Reg #: 3030089798 · FEI: 3030089798 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    HLB LIFE SCIENCE CO., LTD.
    Registration Number
    3030089798
    FEI Number
    3030089798
    Status
    Active
    Expiry Year
    2026
    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
    Syringe, Irrigating (Non Dental) KYZ
    Low Dead Space Piston Syringe QNQ
    Syringe, Antistick MEG

    Proprietary Names

    Membrane Filter Syringe/Sofjec, CarePoint Precision Single use Syringe with/without Needle/Sofjec, CarePoint Precision Single use Needle/Sofjec, CarePoint Precision Irrigation Syringe, Catheter Tip Syringe/Sofjec, CarePoint Precision Single use Syringe with or without Needle/Sofjec, CarePoint Precision Single use Syringe with Needle/Sofjec, CarePoint Precision Single use Membrane Filter Syringe/Sofjec, CarePoint Precision

    Establishment Types

    Manufacture Medical Device