BEUDAMED
    FDA Registration Active 🇮🇳 India

    qER

    Reg #: 3017840913 · FEI: 3017840913 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    QURE.AI TECHNOLOGIES PRIVATE LIMITED
    Registration Number
    3017840913
    FEI Number
    3017840913
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6th Floor, Wing E, Times Square, Andheri-Kurla Road, Marol, Andheri (East),
    City
    Mumbai Maharashtra
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K200921

    Owner / Operator

    Firm Name
    QURE.AI TECHNOLOGIES PRIVATE LIMITED
    Operator Number
    10079068
    Address
    6th Floor, Wing E, Times Square, Andheri-Kurla Road, Marol, Andheri (East),
    City
    Mumbai
    State
    Maharashtra
    Postal Code
    400059
    Country
    IN
    Correspondent
    Bunty Kundnani

    US Agent

    Business Name
    Chief Executive Officer
    Contact Name
    Norman Baylor
    Address
    Biologics Consulting, 100 Daingerfield Rd Ste 400
    City
    Alexandria
    State
    VA
    ZIP
    22314
    Country
    US
    Email
    [email protected]
    Phone
    703 7395695

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS

    Proprietary Names

    qER

    Establishment Types

    Manufacture Medical Device