Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017191859

FEI Number

3017191859

Entity Name

NYXOAH SA

City/State/Country

Mont-Saint-Guibert Brabant Wallon, BE

Establishment Address

Rue Edouard Belin 12, Mont-Saint-Guibert Brabant Wallon 1435, BE

Establishment Type(s)

Manufacture Medical Device

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

Seema Paliwal Business: Nyxoah Inc. Email: seema.paliwal@nyxoah.com Phone: (978) 6026238

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
3030384719	Nyxoah SA Milmort	Herstal Liege, BE
3030384402	NYXOAH INC	Summit, NJ, US

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
3030384719	Nyxoah SA Milmort	Herstal Liege, BE
3008851924	PRONAT INDUSTRIES LTD.	Emek Hefer Ind. Park Haifa, IL
3030384402	NYXOAH INC	Summit, NJ, US
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 3017191859. Last updated year: 2026. Please use registration number 3017191859 when referencing this establishment in official correspondence.