BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    VolparaDensity

    Reg #: 3009117933 · FEI: 3009117933 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    VOLPARA HEALTH TECHNOLOGIES LIMITED
    Registration Number
    3009117933
    FEI Number
    3009117933
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Level 4, 1 Victoria Street
    City
    Wellington Central
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K152028

    Owner / Operator

    Firm Name
    Volpara Health Technologies Limited
    Operator Number
    10034313
    Address
    Level 4, 1 Victoria Street
    City
    Wellington Central
    State
    NZ-WGN
    Postal Code
    6011
    Country
    NZ

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    VolparaDensity

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device