BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    e-ASPECTS

    Reg #: 3017210169 · FEI: 3017210169 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BRAINOMIX LIMITED
    Registration Number
    3017210169
    FEI Number
    3017210169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    First Floor, Seacourt tower, West Way
    City
    Oxford Oxfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K221564

    Owner / Operator

    Firm Name
    Brainomix Limited
    Operator Number
    10076467
    Address
    First Floor, Seacourt Tower, West Way
    City
    Oxford
    State
    Oxfordshire
    Postal Code
    OX2 0JJ
    Country
    GB
    Correspondent
    Zsolt Szrnka

    US Agent

    Business Name
    Freyr Inc
    Contact Name
    Shilpa Gampa
    Address
    150 COLLEGE ROAD WEST, SUITE 102
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US
    Email
    [email protected]
    Phone
    760 5834401

    Products

    Device Name Product Code
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK

    Proprietary Names

    e-ASPECTS Brainomix 360 e-ASPECTS

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198