BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UniStrip1 Generic Blood Glucose Test Strips

    Reg #: 3010622184 · FEI: 3010622184 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    UNISTRIP TECHNOLOGIES, LLC
    Registration Number
    3010622184
    FEI Number
    3010622184
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7224 Statesville Road, Suite A
    City
    Charlotte
    State
    NC
    ZIP
    28269
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162430

    Owner / Operator

    Firm Name
    UniStrip Technologies, LLC
    Operator Number
    10046018
    Address
    7224 Statesville Road, Suite A
    City
    Charlotte
    State
    NC
    Postal Code
    28269
    Country
    US

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    UniStrip1 Generic Blood Glucose Test Strips

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198