BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Assure Lance

    Reg #: 8031690 · FEI: 1000600761 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ASAHI POLYSLIDER COMPANY, LIMITED Okayama-Kuse Plant
    Registration Number
    8031690
    FEI Number
    1000600761
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    860-2 Misaki
    City
    Maniwa Okayama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K222084

    Owner / Operator

    Firm Name
    ASAHI POLYSLIDER COMPANY, LIMITED
    Operator Number
    10026630
    Address
    3-3-3 Nakanoshima, Kita-Ku
    City
    Osaka
    State
    JP-27
    Postal Code
    530-0005
    Country
    JP

    US Agent

    Business Name
    APS America LLC
    Contact Name
    Greg Lamps
    Address
    1850 Parkway Place, Suite 410
    City
    Marietta
    State
    GA
    ZIP
    30067
    Country
    US
    Email
    [email protected]
    Phone
    678 6015370

    Products

    Device Name Product Code
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    Assure Lance Capiject Safety Lancet Assure Lance Plus OneTouch Delica Safety HemoCue Safety Lancet

    Establishment Types

    Manufacture Medical Device