FDA.reportPublic FDA data

Genio System 2.1

Primary DI
05404031018693
Brand
Genio System 2.1
Company
Nyxoah
Model
Genio External Stimulator
Catalog number
NX-PKG-001869
Device description
The External Stimulator is a single-use, sterile accessory that allows the surgeon to activate the Implantable Stimulator and verify the functionality of the implant during the surgical procedure. The External Stimulator contains a power button with an LED indicator, a pre-charged battery and a retractable scaling mechanism to control the stimulation intensity delivered to the implant.
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNQStimulator, Hypoglossal Nerve, Implanted, Apnea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNQStimulator, Hypoglossal Nerve, Implanted, ApneaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240024000Genio® System 2.1Nyxoah S.A.2025-08-08MNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05404031018693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404031018693054040310186935404031018693

GMDN Terms#

Term, Definition table
TermDefinition
Implantable sleep apnoea treatment system, fixed-rateAn assembly of devices intended for home management of obstructive sleep apnoea (OSA) using an implanted stimulator to provide fixed-rate electrical stimulation to the hypoglossal nerve [targeted hypoglossal nerve stimulation (THN)]. It may take two forms: 1) an implanted pulse generator with implanted lead and electrode cuff with a portable patient-operated remote controller/charger; or 2) an unpowered stimulator with paddle electrodes with an external battery-powered control unit which supplies power telemetrically to the implant. It will include dedicated application software used by a healthcare professional for device configuration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400460590
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404031024755Genio System 2.1Genio External Stimulator Sales KitNX-PKG-0035482025-08-26
05404031018723Genio System 2.1Genio Disposable PatchNX-PKG-0018722025-08-27
05404031000001Genio System 2.1Genio Implantable Stimulator Model #2954 with SurgNX-PKG-0029542025-08-26
05404031000018Genio System 2.1Genio Implantable Stimulator Model #2954 Sales KitNX-PKG-0035812025-08-26
05404031000025Genio System 2.1Genio Sleep Lab Application Software2025-08-26
05404031000049Genio System 2.1Genio Smartphone Application Software2025-08-26
05404031024786Genio System 2.1Genio Patient KitNX-PKG-0024782025-08-26
05404031024823Genio System 2.1Genio Charging Unit Model #2238NX-PKG-0024822025-08-26
05404031024847Genio System 2.1Genio Activation Chip Model #2364NX-PKG-0024842025-08-26
05404031025301Genio System 2.1Genio Sleep Lab KitNX-PKG-0025302025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404031018723Genio System 2.1NyxoahMNQ2025-08-27
05404031000001Genio System 2.1NyxoahMNQ2025-08-26
05404031000018Genio System 2.1NyxoahMNQ2025-08-26
05404031000025Genio System 2.1NyxoahMNQ2025-08-26
05404031000049Genio System 2.1NyxoahMNQ2025-08-26
05404031024755Genio System 2.1NyxoahMNQ2025-08-26
05404031024786Genio System 2.1NyxoahMNQ2025-08-26
05404031024823Genio System 2.1NyxoahMNQ2025-08-26
05404031024847Genio System 2.1NyxoahMNQ2025-08-26
05404031025301Genio System 2.1NyxoahMNQ2025-08-26
10855728005793InspireInspire Medical Systems, Inc.MNQ2025-07-29
10810098650295InspireInspire Medical Systems, Inc.MNQ2025-02-24
10810098650301InspireInspire Medical Systems, Inc.MNQ2025-02-24
00810098650311InspireInspire Medical Systems, Inc.MNQ2025-01-21
10855728005960InspireInspire Medical Systems, Inc.MNQ2024-12-06
00810098650175InspireInspire Medical Systems, Inc.MNQ2024-10-10
00810098650199InspireInspire Medical Systems, Inc.MNQ2024-10-10
00855728005994InspireInspire Medical Systems, Inc.MNQ2024-09-11
10810098650264InspireInspire Medical Systems, Inc.MNQ2024-07-08
00810098650038InspireInspire Medical Systems, Inc.MNQ2024-05-15
00810098650212InspireInspire Medical Systems, Inc.MNQ2024-01-03
00810098650151InspireInspire Medical Systems, Inc.MNQ2023-04-26
10810098650141InspireInspire Medical Systems, Inc.MNQ2023-04-06
00810098650014InspireInspire Medical Systems, Inc.MNQ2023-01-13
00810098650083InspireInspire Medical Systems, Inc.MNQ2022-09-29
00855728005796InspireInspire Medical Systems, Inc.MNQ2022-08-16
00855728005949InspireInspire Medical Systems, Inc.MNQ2022-08-16
00855728005925InspireInspire Medical Systems, Inc.MNQ2022-05-09
00810098650007InspireInspire Medical Systems, Inc.MNQ2022-01-26
00855728005741InspireInspire Medical Systems, Inc.MNQ2021-03-19