BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CS Tianjin Lancet Multiple Use

    Reg #: 3008780388 · FEI: 3008780388 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    I-SENS USA, INC.
    Registration Number
    3008780388
    FEI Number
    3008780388
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3545 Lomita Blvd., Unit D
    City
    Torrance
    State
    CA
    ZIP
    90505
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220475

    Owner / Operator

    Firm Name
    i-SENS USA, Inc.
    Operator Number
    10034826
    Address
    3545 Lomita Blvd., Unit D
    City
    Torrance
    State
    CA
    Postal Code
    90505
    Country
    US
    Correspondent
    Jeonghan Ha

    Products

    Device Name Product Code
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    CS Tianjin Lancet Multiple Use CS Tianjin Lancet Single use

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198