GPI USA, INC.

FDA Device Registration & Listing · Houston, TX, US · Registration 3017199812

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017199812
FEI Number
3017199812
Entity Name
GPI USA, INC.
City/State/Country
Houston, TX, US
Establishment Address
2200 Post Oak Blvd, Suite 1000, Houston, TX 77056, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
GPI USA, Inc. (Owner Number: 10076947)
Owner / Operator Contact Address
2200 Post Oak Blvd, Suite 1000, Houston, TX 77056, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK200513
PMA Number
N/A

All Registered Proprietary Names

ElDorado Donor 3 ElDorado Donor 4 Symphony 3 Donor Doc Phlebotomy e-Delphyn Donor e-Delphyn LIS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2020-08-12
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2020-08-05
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2020-08-12
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2020-08-12
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2024-04-10
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2021-06-24

Official Correspondent

Szabolcs Toth

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GPI USA, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017199812. Last updated year: 2026. Please use registration number 3017199812 when referencing this establishment in official correspondence.
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