BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    BRAINOMIX LIMITED

    Reg #: 3017210169 · FEI: 3017210169 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    BRAINOMIX LIMITED
    Registration Number
    3017210169
    FEI Number
    3017210169
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    First Floor, Seacourt tower, West Way
    City
    Oxford Oxfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K243294

    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
    777 Scudders Mill Road, Building 2, Suite 150
    City
    Plainsboro
    State
    NJ
    ZIP
    08536
    Country
    US
    Email
    [email protected]
    Phone
    760 5834401

    Products

    Device Name Product Code
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK
    Radiological Computer-Assisted Triage And Notification Software QAS
    System, Image Processing, Radiological LLZ
    System, X-Ray, Tomography, Computed JAK
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Brainomix 360 e-ASPECTS e-ASPECTS Triage Stroke Brainomix 360 Triage Stroke Brainomix 360 e-CTP e-CTP Brainomix 360 e-Lung e-Lung Brainomix 360 e-MRI e-MRI Brainomix 360 e-CTA e-CTA Brainomix 360 Triage LVO Triage LVO Brainomix 360 Triage ICH Triage ICH

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device