Genio System 2.1 NX-PKG-002954

GUDID 05404031000001

The Implantable Stimulator Model #2954 is a single-use, sterile, small saddle-shaped implant that delivers stimulation to both hypoglossal nerve branches (i.e. left and right). The body of the Implantable Stimulator consists of an energy receiving antenna and an electrical circuit both encapsulated in a ceramic housing, and two lateral legs with a pair of paddle electrodes. It is powered and controlled by either the Activation Chip or External Stimulator externally. The Implantable Stimulator does not include a battery or a microcontroller or software. Packaged with the Implantable Stimulator Model #2954 is the Surgical Template. The Surgical Template is a single use, sterile accessory which can be optionally used for preparation of the implantation site.

Nyxoah

Implantable sleep apnoea treatment system, fixed-rate

• Primary Device ID: 05404031000001
• NIH Device Record Key: c019996a-34b4-4a62-a9ac-b19fab10fdde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genio System 2.1
• Version Model Number: Genio Implantable Stimulator Model #2954 with Surg
• Catalog Number: NX-PKG-002954
• Company DUNS: 400460590
• Company Name: Nyxoah
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05404031000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240024

FDA Product Code

• MNQ: Stimulator, Hypoglossal Nerve, Implanted, Apnea

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-03
• Device Publish Date: 2025-08-26

On-Brand Devices [Genio System 2.1]

• 05404031025301: The Genio Sleep Lab Kit is comprised of the Repeater containing the Genio Sleep Lab Application,
• 05404031024847: The Activation Chip is the power source for the Implantable Stimulator. The Activation Chip cont
• 05404031024823: The Charging Unit and its power adapter are used to recharge the Activation Chip battery during
• 05404031024786: The Genio Patient Kit contains one Activation Chip Model #2364 (Primary DI: 05404031024847) one
• 05404031024755: The Genio External Stimulator Sales Kit includes one External Stimulator (Primary DI: 0540403101
• 05404031018693: The External Stimulator is a single-use, sterile accessory that allows the surgeon to activate t
• 05404031000049: The Activation Chip can be controlled by an optional Genio Smartphone Application software, desi
• 05404031000025: The Genio Sleep Lab Application software is used to configure the Activation Chip stimulation pa
• 05404031000018: The Genio Implantable Stimulator Model #2954 Sales Kit contains one Implantable Stimulator Model
• 05404031000001: The Implantable Stimulator Model #2954 is a single-use, sterile, small saddle-shaped implant tha
• 05404031018723: The Disposable Patch is a single-use adhesive patch placed on the skin under the chin each night