BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nova Max

    Reg #: 3004193489 · FEI: 3004193489 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS
    Registration Number
    3004193489
    FEI Number
    3004193489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    39 Manning Rd
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070255

    Owner / Operator

    Firm Name
    NOVA BIOMEDICAL CORP.
    Operator Number
    1219029
    Address
    200 PROSPECT ST., --
    City
    Waltham
    State
    MA
    Postal Code
    02454
    Country
    US
    Correspondent
    John F McHale

    Products

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

    Proprietary Names

    Nova Max Menarini GlycoPC Menarini Glucomen Lx

    Establishment Types

    Manufacture Device in the United States for Export Only Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device