BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    LUNIT INTERNATIONAL LIMITED

    Reg #: 3009117933 · FEI: 3009117933 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    LUNIT INTERNATIONAL LIMITED
    Registration Number
    3009117933
    FEI Number
    3009117933
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Level 4, 1 Victoria Street
    City
    Wellington Central
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K211279

    Owner / Operator

    Firm Name
    Lunit International 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
    Instrument, Quality-Assurance, Radiologic LHO
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Volpara Live Volpara Scorecard

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device