BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Affinity

    Reg #: 9710645 · FEI: 3002831423 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HERMES MEDICAL SOLUTIONS, AB
    Registration Number
    9710645
    FEI Number
    3002831423
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Strandbergsgatan 16
    City
    STOCKHOLM
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K202882

    Owner / Operator

    Firm Name
    HERMES MEDICAL SOLUTIONS AB
    Operator Number
    9047204
    Address
    Strandbergsgatan 16, --
    City
    STOCKHOLM
    State
    SE-AB
    Postal Code
    11251
    Country
    SE

    US Agent

    Business Name
    Hermes Medical Solutions Inc
    Contact Name
    Christine Dempsey
    Address
    2120 E. Fire Tower Rd, #107-197
    City
    Greenville
    State
    NC
    ZIP
    27858
    Country
    US
    Email
    [email protected]
    Phone
    252 7510664

    Products

    Device Name Product Code
    System, Tomography, Computed, Emission KPS

    Proprietary Names

    Affinity Affinity Viewer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device