BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GlucoCare Intensive Glycemic Control System

    Reg #: 3014174631 · FEI: 3028631080 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PRONIA MEDICAL SYSTEMS
    Registration Number
    3014174631
    FEI Number
    3028631080
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    803 Springhouse Dr
    City
    Lewisburg
    State
    PA
    ZIP
    17837
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081388

    Owner / Operator

    Firm Name
    Pronia Medical Systems
    Operator Number
    10028182
    Address
    22 West Road
    City
    South Salem
    State
    NY
    Postal Code
    10590
    Country
    US

    Products

    Device Name Product Code
    Calculator, Drug Dose NDC

    Proprietary Names

    GlucoCare Intensive Glycemic Control System

    Establishment Types

    Manufacture Medical Device