Genio System 2.1 NX-PKG-002484

GUDID 05404031024847

The Activation Chip is the power source for the Implantable Stimulator. The Activation Chip contains a rechargeable battery, electronics for Bluetooth communication and electromagnetic power transmission, and a microprocessor that stores the user-specific stimulation parameters. The Activation Chip must be connected to the Disposable Patch and placed on the chin each night for stimulation to be delivered, and the battery must be recharged daily.

Nyxoah

Implantable sleep apnoea treatment system, fixed-rate

• Primary Device ID: 05404031024847
• NIH Device Record Key: 42b18358-476f-42e7-b7a2-f350b81c1352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genio System 2.1
• Version Model Number: Genio Activation Chip Model #2364
• Catalog Number: NX-PKG-002484
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	05404031024847 [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: false

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