BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GPI USA, INC.

    Reg #: 3017199812 · FEI: 3017199812 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GPI USA, INC.
    Registration Number
    3017199812
    FEI Number
    3017199812
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2200 Post Oak Blvd, Suite 1000
    City
    Houston
    State
    TX
    ZIP
    77056
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK150308

    Owner / Operator

    Firm Name
    GPI USA, Inc.
    Operator Number
    10076947
    Address
    2200 Post Oak Blvd, Suite 1000
    City
    Houston
    State
    TX
    Postal Code
    77056
    Country
    US
    Correspondent
    Szabolcs Toth

    Products

    Device Name Product Code
    Blood Establishment Computer Software And Accessories MMH

    Proprietary Names

    ElDorado Donor 3 ElDorado Donor 4 Symphony 3 Donor Doc Phlebotomy e-Delphyn Donor e-Delphyn LIS e-Delphyn Donor 11 SafeTrace Surround 5.1 Donor Doc 3

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device