Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042226194

FEI Number

3042226194

Entity Name

BEATS MEDICAL

City/State/Country

Sandyford Dublin, IE

Establishment Address

Hub 17, 17 Corrig Road, Sandyford Dublin D18 N6K8, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beats Medical (Owner Number: 10094430)

Owner / Operator Contact Address

Hub 17, 17 Corrig Road, Sandyford, IE-D D18 N6K8, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Beats Medical Application

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2025-11-28

Official Correspondent

Ciara Clancy

US Agent Details

Jacqueline Lutz Business: LUJA consulting LLC Email: jlutz@luja-consulting.com Phone: (857) 2459411

Related Public Records

Same Entity

Beats Medical

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
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17
K792659	Bio-Feedback Systems, Inc.	FEEDBACK EDR SYSTEM MODEL ME-1	1980-01-09

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3011255064	RAYONEX BIOMEDICAL GMBH	Lennestadt North Rhine-Westphalia, DE
3038620647	KISO EHF	Reykjavik, IS
3005196642	HARMONIC ENERGETIC TECHNOLOGIES, LLC	Liverpool, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042226194. Last updated year: 2026. Please use registration number 3042226194 when referencing this establishment in official correspondence.