BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Glucometer

    Reg #: 3003674698 · FEI: 3003674698 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MedSource Labs, LLC
    Registration Number
    3003674698
    FEI Number
    3003674698
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8600 Shelby Court, Suite 100
    City
    Chanhassen
    State
    MN
    ZIP
    55317
    Country
    US

    Regulatory Submissions

    510(k) Number
    K082965

    Owner / Operator

    Firm Name
    MEDSOURCE LABS, LLC
    Operator Number
    9050135
    Address
    8600 Shelby Court, Suite 100, --
    City
    Chanhassen
    State
    MN
    Postal Code
    55317
    Country
    US
    Correspondent
    Emilie Andrews

    Products

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

    Proprietary Names

    Glucometer Glucometer test strips Glucometer test solution Glucometer lancets

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198