BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    SyMRI

    Reg #: 3014111222 · FEI: 3014111222 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SYNTHETICMR AB
    Registration Number
    3014111222
    FEI Number
    3014111222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Storgatan 11
    City
    Linkoping Ostergotland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K173558

    Owner / Operator

    Firm Name
    SyntheticMR AB
    Operator Number
    10056087
    Address
    Storgatan 11
    City
    Linkoping
    State
    SE-NOTA
    Postal Code
    SE-582 23
    Country
    SE

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    SyMRI

    Establishment Types

    Manufacture Medical Device