Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027997270

FEI Number

3027997270

Entity Name

NEUROVALENS

City/State/Country

Belfast, GB

Establishment Address

7 James St South, The Warehouse Floor 4, Belfast BT2 8DN, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neurovalens (Owner Number: 10089371)

Owner / Operator Contact Address

651 N. Broad Street, Suite 206, Middletown, DE 19709, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN250013

PMA Number

N/A

All Registered Proprietary Names

Modius Sleep Modius Calm Modius Lean Modius Skin Wipes Modius Spero

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJQ	Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety	Neurology	Class 2	882.5800	2023-12-01
QJQ	Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety	Neurology	Class 2	882.5800	2024-03-30
SFW	Cranial Electrotherapy Stimulator For Weight Management	Gastroenterology, Urology	Class 1	876.5984	2026-04-22
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2025-01-10
SHX	Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms	Neurology	Class 2	882.5807	2026-06-16

Official Correspondent

Jason McKeown

US Agent Details

Edwin Lindsay Business: RAF SOLUTIONS, INC Email: edwin@rafsolutions.net Phone: (305) 9607262

Related Public Records

Same Entity

Neurovalens

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 3027997270. Last updated year: 2026. Please use registration number 3027997270 when referencing this establishment in official correspondence.