BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RASIMO SYSTEMS LLC

    Reg #: 3042026207 · FEI: 3042026207 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    RASIMO SYSTEMS LLC
    Registration Number
    3042026207
    FEI Number
    3042026207
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4801 Glenwood Ave Ste 200
    City
    Raleigh
    State
    NC
    ZIP
    27612
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161738

    Owner / Operator

    Firm Name
    Rasimo Systems LLC
    Operator Number
    10094074
    Address
    4801 Glenwood Ave Suite 200
    City
    Raleigh
    State
    NC
    Postal Code
    27612
    Country
    US
    Correspondent
    Sarfraz Khokhar

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN

    Proprietary Names

    SureMediks Keto-Pro Plus SureMediks Beta-Ketone Test Strips SureMediks Blood Glucose Test Strips

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility