FDA.reportPublic FDA data

Genio System 2.1

Primary DI
05404031000049
Brand
Genio System 2.1
Company
Nyxoah
Model
Genio Smartphone Application Software
Device description
The Activation Chip can be controlled by an optional Genio Smartphone Application software, designed to operate on both Android and iOS devices. The Smartphone Application software allows the patient to pause and resume stimulation and to increase/decrease the treatment amplitude within a pre-configured range. The Smartphone Application software uses Bluetooth low energy (BLE) protocol to communicate with a paired Activation Chip.
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
05404031000049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404031000049054040310000495404031000049

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
Serial number
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
05404031018693Genio System 2.1Genio External StimulatorNX-PKG-0018692025-08-26
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
05404031018693Genio 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