BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    MEDRAD® Spectris Solaris EP MR Injection System

    Reg #: 3011334555 · FEI: 3011334555 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Bayer Medical SRL
    Registration Number
    3011334555
    FEI Number
    3011334555
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block B Lot 1, Metro Park
    City
    Barreal de Heredia
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K042784

    Owner / Operator

    Firm Name
    Bayer Medical Care Inc.
    Operator Number
    2520313
    Address
    1 Bayer Drive
    City
    Indianola
    State
    PA
    Postal Code
    15051
    Country
    US
    Correspondent
    Troy A Jack

    US Agent

    Business Name
    Bayer Medical Care, Inc.
    Contact Name
    Troy Jack
    Address
    1 Bayer Drive
    City
    Indianola
    State
    PA
    ZIP
    15051
    Country
    US
    Email
    [email protected]
    Phone
    412 3528280

    Products

    Device Name Product Code
    Injector And Syringe, Angiographic DXT

    Proprietary Names

    MEDRAD® Spectris Solaris EP MR Injection System MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve MEDRAD® Disposable MRI Kit for 65/115 MR Injector System MEDRAD® Saline Syringe & Tubing for MR Injector System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)