Our results are not declarative claims. They are measured, certified, and fully traceable.

Our devices have been developed according to the EN ISO 13485 framework — the international standard governing the design and manufacture of medical devices. We apply it voluntarily, even though our products are not medical devices in Europe, because it imposes a level of rigor we consider the minimum acceptable.

In practical terms, this means:

• Formalized and verified user needs — each product is developed from amatrix linking user needs to technical specifications, verified at every stage of design.
• Testing at every development phase — functional, technical, and performancechecks on prototypes, then on the final product, before any production launch.
• 100% testing in production — each device is tested individually: battery life andperformance, irradiance measured by wavelength, LED accuracy,connections. These results are part of the batch record that determines product release.
• Full traceability — every product is traceable end to end, from component todelivered product.

In addition, we commission SGS — an independent laboratory and global leader in inspection, testing, and certification, present in 115 countries — to objectively verify the compliance and performance of every NOOĀNCE Beauty Tech product upon receipt.

This level of rigor is precisely what allows us to present clinical study figureswith confidence, because we know that the product tested in the laboratory is identical to the productyou receive.

Our devices are manufactured in China, by an industrial partner certified EN ISO 13485, the quality management standard for medical devices, as well as MDSAP, the single audit program recognized internationally in the United States, Canada, Australia, Brazil and Japan.

The geographic origin of a product says nothing about its quality. What determines it is the level of rigor applied at every stage. And on this point, NOOĀNCE makes no compromises.

What sets our devices apart from a generic product is our ability to design, develop and control manufacturing from end to end:

• Proprietary molds we have our molds custom-made. Our devices are not white-label products.
• Dedicated technical specifications each product is developed and qualified according to our own criteria and specifications. Our LEDs are supplied by the world leader in the field, qualified for medical use according to the IEC 60601 series of standards, including IEC 60601-2-57. Our internal layers in contact with the skin are made of medical-grade silicone.
• Biological testing on the finished product the product in contact with the skin is tested according to the EN ISO 10993-5 (cytotoxicity), EN ISO 10993-10 (skin sensitization) and EN ISO 10993-23 (skin irritation) standards, references in the biological evaluation of medical devices.
• Safety and performance testing on finished products electrical safety, electromagnetic compatibility, substance compliance (RoHS, REACH, ISO 10993), carried out byindependent laboratories.
• Individual testing during production each device is tested one by one: irradiance, wavelength accuracy, charging time, battery life, charging cycle compliance,light indicators, temperature rise.
• Batch release by NOOĀNCE each batch of products undergoes an internal control and release process, based on the batch record provided by our subcontractor.
• Additional testing by SGS France additional tests may be carried out periodically by SGS France, an internationally recognized independent testing laboratory.
• EN ISO 13485 certification since 2025, NOOĀNCE has implemented aquality management system meeting the requirements of this standard, withdocumented processes tracked across design, post-market surveillance, quality assurance andproduct release.
• Annual Bureau Veritas audit as part of our EN ISO 13485 certification, an independent annual audit is carried out by Bureau Veritas to verify compliance of our quality system.

This is not assembly. This is engineering.

Where are your cosmetic products and dietary supplements formulated and manufactured?

All of our cosmetics, serums, creams, treatments and our 360° Beauty Concentrate - dietary supplement are formulated and manufactured in France. We work with French partner laboratories, selected for their expertise and the rigor of their manufacturing processes.

This choice reflects our commitment to quality, traceability and support for the French cosmetics andnutraceutical industry.