Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004695199

FEI Number

3004695199

Entity Name

INCEREB LTD

City/State/Country

Dublin Dun Laoghaire-Rathdown, IE

Establishment Address

6 Charlemont Terrace, Crofton Road, Dun Laoghaire, Dublin Dun Laoghaire-Rathdown A96 F8W5, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Incereb Ltd (Owner Number: 10051067)

Owner / Operator Contact Address

6 Charlemont Terrace, Crofton Road, Dun Laoghaire, Dublin, IE-DR A96 F8W5, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151576

PMA Number

N/A

All Registered Proprietary Names

neon12 neon6 neon8 NEON EEG Neon12 KIT Neon8 KIT Neon10 Neon10 NeuroBell

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2016-02-01

Official Correspondent

Paul Phillips

US Agent Details

Marshall Rest Business: Lifelines Neuro Company, LLC Email: alex.rest@lifelinesneuro.com Phone: (618) 6676445

Related Public Records

Same Entity

Incereb Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004695199. Last updated year: 2026. Please use registration number 3004695199 when referencing this establishment in official correspondence.