BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SureComfort Safety Lancet

    Reg #: 3024273968 · FEI: 3024273968 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HLB CO., LTD. HEALTHCARE
    Registration Number
    3024273968
    FEI Number
    3024273968
    Status
    Active
    Expiry Year
    2025
    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
    J.S. Chem International Co.
    Contact Name
    Grace Kim
    Address
    20155 Pingree Way
    City
    Yorba Linda
    State
    CA
    ZIP
    92887
    Country
    US
    Email
    [email protected]
    Phone
    310 5983012

    Products

    Device Name Product Code
    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

    SureComfort Safety Lancet Sterilized Eol Lancet Plus Sterilized Eol Auto Lancet

    Establishment Types

    Manufacture Medical Device