BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HLB CO., LTD. HEALTHCARE

    Reg #: 3024273968 · FEI: 3024273968 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    HLB CO., LTD. HEALTHCARE
    Registration Number
    3024273968
    FEI Number
    3024273968
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10-5 Myeonghaksandanseo-ro
    City
    Yeondong-myeon Sejong
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K243533

    Owner / Operator

    Firm Name
    HLB Co., LTD. Healthcare
    Operator Number
    10087138
    Address
    10-5 Myeonghaksandanseo-ro
    City
    Yeondong-myeon
    State
    Sejong
    Postal Code
    30068
    Country
    KR

    US Agent

    Business Name
    SMB USA LLC.
    Contact Name
    HUICHAO LEE
    Address
    44855 Lafayette Dr
    City
    Novi
    State
    MI
    ZIP
    48377
    Country
    US
    Email
    [email protected]
    Phone
    734 6297552

    Products

    Device Name Product Code
    Dental Hygiene Kit NXZ
    Applicator, Absorbent Tipped, Sterile KXG
    Pad, Alcohol, Device Disinfectant LKB
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    Oral care tissue Gum & Tooth care wipes Sponge foam Swab Nasopharyngeal Swab Throat Swab Oropharyngeal Swab Nasal Swab Specimen Collection Swab Collection Swab Cotton Swab SureComfort Alcohol Prep Pads Nosting Swab CareSens Alcohol Prep Pads Alcohol Swab(Isopropyl Alcohol) Sanitizer Swab Eol Swab (Ethanol) FA Alcohol Swab S SureComfort Safety Lancet Sterilized Eol Auto Lancet Sterilized Eol Lancet Plus

    Establishment Types

    Manufacture Medical Device