Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018030059

FEI Number

3018030059

Entity Name

NEUROMOD DEVICES LIMITED

City/State/Country

Dublin Dublin (City), IE

Establishment Address

Rainsford Street, Dublin Dublin (City) D08 R2YP, IE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neuromod Devices Limited (Owner Number: 10087563)

Owner / Operator Contact Address

Rainsford Street, Dublin, IE-DU D08 R2YP, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN210033

PMA Number

N/A

All Registered Proprietary Names

Lenire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QVN	Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus	Ear, Nose, Throat	Class 2	874.3410	2023-03-15

Official Correspondent

Fran Coogan

US Agent Details

Tish Ramirez Email: tish.ramirez@neuromoddevices.com Phone: (630) 5416539

Related Public Records

Same Entity

Neuromod Devices Limited

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 3018030059. Last updated year: 2026. Please use registration number 3018030059 when referencing this establishment in official correspondence.