Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042167929

FEI Number

3042167929

Entity Name

GEROA DIAGNOSTICS SOCIEDAD LIMITADA

City/State/Country

Vitoria Alava, ES

Establishment Address

Avenida de Budapest, 50-B, Vitoria Alava 01003, ES

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

GEROA DIAGNOSTICS SOCIEDAD LIMITADA (Owner Number: 10094336)

Owner / Operator Contact Address

Avenida de Budapest, 50-B, Vitoria, ES-VI 01003, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GEROADX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DEG	Lactoferrin, Antigen, Antiserum, Control	Immunology	Class 1	866.5570	2025-11-24

Official Correspondent

Juan Carlos Del Castillo

US Agent Details

Takahiro Haruyama Business: GLOBIZZ CORPORATION Email: register@globizz.net Phone: (310) 5383833

Related Public Records

Same Entity

GEROA DIAGNOSTICS SOCIEDAD LIMITADA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042167929. Last updated year: 2026. Please use registration number 3042167929 when referencing this establishment in official correspondence.