BEUDAMED
    Basic UDI-DI Eu Mdr Eu Md Class 2a 🇺🇸 United States

    Swoop® Portable MR Imaging® System

    Code: 0860000606100001R3
    View on EUDAMED
    Devices
    1
    Certificates
    0
    Notified Bodies
    0
    Auth. Representatives
    1

    Basic Information

    UDI-DI Code
    0860000606100001R3
    Issuing Agency
    GS1
    Device Model
    900-11001-06, 900-11001-05
    Types
    Active
    Regulation
    Eu Mdr
    Classification
    Eu Md Class 2a
    Manufacturer
    Hyperfine, Inc.
    Last Updated
    February 18, 2025

    Certificate Health

    No certificates associated with this Basic UDI-DI.

    Associated Devices

    This Basic UDI-DI is associated with 1 device.

    Name Status
    Swoop® Portable MR Imaging® System On the market