Revée® medical devices are CE marked (Declaration of Conformity) in accordance with the MDR (EU Regulation 2017/745), and their design and production management are certified to UNI EN ISO 9001:2015, a quality management system that ensures continuous improvement of business processes and customer satisfaction, by TÜV Italia. The Revée Sun /Care 50+ sunscreen and the Revée OIL dry base oil are registered as cosmetics according to Regulation (EC) No. 1223/2009.
Our goal is to provide products of the highest quality, ensure timely deliveries, and offer excellent service to our customers, committing to meet and exceed their requirements and regulatory standards while continuously maintaining and improving the effectiveness of our quality management system.
UNI EN ISO 9001:2015
ISO 9001 certification guarantees quality and efficiency in business processes, improving reliability, competitiveness, and final customer satisfaction.
UNI CEI EN ISO 13485:2021
ISO 13485 certification ensures quality and safety in medical devices, guaranteeing regulatory compliance and reliability in production processes.
Quality agreement
Revée guarantees innovation, safety, and reliability by offering certified devices, continuously improving its standards and performance.
FDA Registered
The FDA (Food and Drug Administration) is the United States government agency that regulates and certifies the safety and effectiveness of drugs, medical devices, and food.
Medical Devices (MDR)
The MDR (EU Regulation 2017/745) sets strict requirements for the safety, quality, and traceability of medical devices, ensuring greater protection for patients.
CE Declaration of Conformity for Garments
The CE Declaration certifies that the product complies with European standards, ensuring safety and quality.
CE Declaration of Conformity for Gel
The CE Declaration certifies that the product complies with European standards, ensuring safety and quality.
