BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LifeScan U.S. LLC

    Reg #: 3042301847 · FEI: 3042301847 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    LifeScan U.S. LLC
    Registration Number
    3042301847
    FEI Number
    3042301847
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    75 Valley Stream Pkwy
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053529

    Owner / Operator

    Firm Name
    LifeScan U.S. LLC
    Operator Number
    10094560
    Address
    75 Valley Stream Pkwy
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Amber Wingler

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    OneTouch Ultra 2 Meter OneTouch Ultra 2 Blood Glucose Monitoring System OneTouch Ultra Blue Test Strips OneTouch Select Blood Glucose Meter OneTouch Select Test Strips OneTouch Select Blood Glucose Monitoring System OneTouch UltraMini Blood Glucose Monitoring System OneTouch UltraMini Meter OneTouch Select Control Solutions OneTouch Ultra Control Solutions

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility