Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007360698

FEI Number

3007360698

Entity Name

OPERON, S.A.

City/State/Country

CUARTE DE HUERVA Zaragoza, ES

Establishment Address

CAMINO DEL PLANO 19, CUARTE DE HUERVA Zaragoza 50410, ES

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OPERON, S.A. (Owner Number: 10027482)

Owner / Operator Contact Address

CAMINO DEL PLANO 19, CUARTE DE HUERVA, ES-Z 50410, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ImmunoCard STAT! HpSA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2008-11-12

Official Correspondent

DANIEL TORIBIO RENNER

US Agent Details

SUSAN BOGAR Business: MERIDIAN BIOSCIENCE Email: susan.bogar@meridianbioscience.com Phone: (513) 2713700

Related Public Records

Same Entity

OPERON, S.A.

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 3007360698. Last updated year: 2026. Please use registration number 3007360698 when referencing this establishment in official correspondence.