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Certifications And Homologation

3 certifications – 7 approvals – Safety – Satisfaction

The Biolux team is fully committed to quality at every level of the company. This allows us to offer innovative, effective, high-quality products designed to meet market needs and fulfil applicable safety regulations.

Quality Policy Focuses onContinuous Improvement

Biolux guarantees its devices and treatments are safe and conform to applicable regulations. But we don’t stop there: we work to continuously improve and anticipate potential institutional barriers.

Products ApprovedAround the World

Our professional products have been approved around the world:

  • European Union
  • Switzerland
  • United States of America
  • Canada (approval in process)
  • Brazil (approval in process)
  • Maghreb (approval in process)

Biolux ISO 9001 and ISO 13485 Certified

ISO 9001 and ISO 13485 are international standards on quality management systems.

  • ISO 9001 outlines and validates design processes and continuous improvement commitments
  • ISO 13485 specifies regulatory requirements for quality management systems for the medical device industry.

Biolux Device Received CE MEDICAL Marking

Instruments with the CE marking conform to essential requirements defined by the 14 June 1993 directive 93/42/CEE concerning medical devices (recently amended by the 2007/47/CE directive). CE marking guarantees that using the device will not compromise a patient’s clinical state or safety, or the safety and health of users. It is understood that potential risks linked to using the device constitute acceptable risks in relation to the benefits a patient receives and are compatible with a high level of health and safety protection.

Biolux device Approved As Elyx

The Food and Drug Administration (FDA) is the American federal agency governing the healthcare and food industries. FDA approval is required for all medical devices in the United States.

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