Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030384402

FEI Number

3030384402

Entity Name

NYXOAH INC

City/State/Country

Summit, NJ, US

Establishment Address

350 Springfield Ave Ste 200, Summit, NJ 07901, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Nyxoah SA Mont Saint Guibert (Owner Number: 10093936)

Owner / Operator Contact Address

Rue Edouard Belin 12, Mont-Saint-Guibert, BE-NOTA 1435, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P240024

All Registered Proprietary Names

Genio

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNQ	Stimulator, Hypoglossal Nerve, Implanted, Apnea	Unknown	Class 3	N/A	2025-08-13

Official Correspondent

Seema Paliwal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nyxoah SA Mont Saint Guibert

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017191859	NYXOAH SA	Mont-Saint-Guibert Brabant Wallon, BE
3030384719	Nyxoah SA Milmort	Herstal Liege, BE

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2025	Inspire Medical Systems Inc.	3	Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Z-0041-2025	Inspire Medical Systems Inc.	3	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Similar Registrations

Registration Number	Establishment Name	Location
3030499299	Inspire Medical Systems Inc	Golden Valley, MN, US
3017191859	NYXOAH SA	Mont-Saint-Guibert Brabant Wallon, BE
3030384719	Nyxoah SA Milmort	Herstal Liege, BE
3008851924	PRONAT INDUSTRIES LTD.	Emek Hefer Ind. Park Haifa, IL
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030384402. Last updated year: 2026. Please use registration number 3030384402 when referencing this establishment in official correspondence.