Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004072823

FEI Number

3004072823

Entity Name

FABRINAL SA

City/State/Country

LA CHAUX-DE-FONDS Neuchatel, CH

Establishment Address

RUE DE LA TUILERIE 42, LA CHAUX-DE-FONDS Neuchatel CH-2300, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fabrinal (Owner Number: 9089180)

Owner / Operator Contact Address

RUE DE LA TUILERIE 42, --, LA CHAUX-DE-FONDS, CH-NE CH-2300, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K830557

PMA Number

N/A

All Registered Proprietary Names

ERG Jet Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLZ	Electrode, Corneal	Ophthalmic	Class 2	886.1220	2006-06-28

Official Correspondent

Cloe Houriet

US Agent Details

Joseph Azary Business: Aztech Regulatory and Quality LLC Email: aztechregulatory@gmail.com Phone: (203) 2426670

Related Public Records

Same Entity

Fabrinal

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 3004072823. Last updated year: 2026. Please use registration number 3004072823 when referencing this establishment in official correspondence.