BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Spectra Optia Single Needle TPE

    Reg #: 3020981987 · FEI: 3020981987 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TFB MANUFACTURING SRL
    Registration Number
    3020981987
    FEI Number
    3020981987
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calle 58, Zona Franca La Lima, Planta de Terumo BCT - Calle Duan y Avenida Turrialba
    City
    La Lima, Guadalupe Cartago
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K131744

    Owner / Operator

    Firm Name
    Terumo BCT, INC.
    Operator Number
    9002708
    Address
    10811 WEST COLLINS AVE., --
    City
    Lakewood
    State
    CO
    Postal Code
    80215
    Country
    US
    Correspondent
    Corrine Lucas

    US Agent

    Business Name
    TERUMO BCT, INC.
    Contact Name
    Corrine Lucas
    Address
    10811 WEST COLLINS AVE., --
    City
    Lakewood
    State
    CO
    ZIP
    80215
    Country
    US
    Email
    [email protected]
    Phone
    720 6106034

    Products

    Device Name Product Code
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN

    Proprietary Names

    Spectra Optia Single Needle TPE Spectra Optia Exchange Set Spectra Optia Single-Needle Connector

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)