Genio System 2.1 NX-PKG-001869

GUDID 05404031018693

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.

Nyxoah

Implantable sleep apnoea treatment system, fixed-rate

• Primary Device ID: 05404031018693
• NIH Device Record Key: a368e32e-d447-4e22-8770-a697d154454b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genio System 2.1
• Version Model Number: Genio External Stimulator
• Catalog Number: NX-PKG-001869
• Company DUNS: 400460590
• Company Name: Nyxoah
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	05404031018693 [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