BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    FlexCath Cross™ Transseptal Solution

    Reg #: 3013666336 · FEI: 3013666336 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Heraeus Medical Components, SRL
    Registration Number
    3013666336
    FEI Number
    3013666336
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parque Industrial Zona Franca La Lima, Building 29
    City
    Guadalupe Cartago
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K233691

    Owner / Operator

    Firm Name
    Heraeus Medical Components, LLC
    Operator Number
    9045241
    Address
    5030 Centerville Road
    City
    Saint Paul
    State
    MN
    Postal Code
    55127
    Country
    US
    Correspondent
    Timothy Desaulniers

    US Agent

    Business Name
    Heraeus Medical Components, LLC
    Contact Name
    Timothy Desaulniers
    Address
    5030 Centerville Road
    City
    Saint Paul
    State
    MN
    ZIP
    55127
    Country
    US
    Email
    [email protected]
    Phone
    612 3252003

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    FlexCath Cross™ Transseptal Solution

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)