BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Accu-Chek Safe-T-Pro Plus Lancing Device

    Reg #: 8031690 · FEI: 1000600761 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K232488

    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

    Accu-Chek Safe-T-Pro Plus Lancing Device

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)