BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    SCREENPOINT MEDICAL

    Reg #: 3015173173 · FEI: 3015173173 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    SCREENPOINT MEDICAL
    Registration Number
    3015173173
    FEI Number
    3015173173
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Mercator II, 7th floor, Toernooiveld 300
    City
    Nijmegen Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K241831

    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
    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
    Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer QDQ
    Automated Radiological Image Processing Software QIH
    System, Digital Image Communications, Radiological LMD

    Proprietary Names

    Transpara Transpara SR Converter Transpara 1.7.y Transpara 1.7.2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device