Company: NYXH
Filing Date: 2025-08-11
Form Type: 6-K
Source: 0001104659-25-075831
Chunk: 8

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 8
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may limit the potential commercial market for the device.

On August 8, 2025, we announced
that the U.S. Food and Drug Administration, or FDA, granted approval of the Genio® system for a subset of patients with moderate to
severe Obstructive Sleep Apnea (OSA) with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. In
order to sell our products in member countries of the European Union, or the EU, our products must comply with the essential requirements
of the EU Medical Devices Directive (Council Directive 93/42/EEC), the Active Implantable Medical Devices Directive (Council Directive
90/385/EEC) or Medical Device Regulation (EU) 2017/745 of the European Parliament. Compliance with these requirements is a prerequisite
to be able to affix the European Conformity, or CE, mark to our products, without which they cannot be sold or marketed in the EU. To
demonstrate compliance with the essential requirements we must undergo a conformity assessment procedure, which varies according to the
type of medical device and its risk classification. Except for low-risk medical devices (Class I non-sterile, non-measuring devices),
where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the
essential requirements of the EU Medical Devices Directive (for devices entering the EU market prior to May 26, 2021) or the Medical Device
Regulation (for devices entering the EU market on or after May 26, 2021), a conformity assessment procedure requires the intervention
of an organization accredited or designated by a member state of the EU to conduct conformity assessments to the applicable legal requirements,
or a Notified Body. Depending on the relevant conformity assessment procedure, the Notified Body would typically audit and examine the
technical file and the quality system for the manufacture, design and final inspection of our devices. The Notified Body issues a certificate
of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its
manufacturer and their conformity with the essential requirements. This certificate entitles the manufacturer to affix the CE-Mark to
its medical devices after having prepared and signed a related EC Declaration of Conformity.

As a general rule, demonstration
of conformity of medical devices and their manufacturers with the essential requirements must be based, among other