BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Transpara

    Reg #: 3015173173 · FEI: 3015173173 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SCREENPOINT MEDICAL
    Registration Number
    3015173173
    FEI Number
    3015173173
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Mercator II, 7th floor, Toernooiveld 300
    City
    Nijmegen Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K232096

    Owner / Operator

    Firm Name
    ScreenPoint Medical
    Operator Number
    10059521
    Address
    Mercator II, 7th floor, Toernooiveld 300
    City
    Nijmegen
    State
    Gelderland
    Postal Code
    6525 EC
    Country
    NL

    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
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    Transpara

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198