BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prodigy Diabetes Management Software

    Reg #: 3008789114 · FEI: 3008789114 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PRODIGY DIABETES CARE, LLC
    Registration Number
    3008789114
    FEI Number
    3008789114
    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
    K103115

    Owner / Operator

    Firm Name
    Prodigy Diabetes Care, LLC
    Operator Number
    10033726
    Address
    7224 Stateville Road, Suite A
    City
    Charlotte
    State
    NC
    Postal Code
    28269
    Country
    US

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Calculator/Data Processing Module, For Clinical Use JQP

    Proprietary Names

    Prodigy Diabetes Management Software

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198