Globally Certified & Registered
ANF Devices are fully certified and compliant with international medical standards, ensuring their safety and effectiveness for use in healthcare settings.
ANF Devices are fully certified and compliant with international medical standards, ensuring their safety and effectiveness for use in healthcare settings. The devices are registered and approved as follows:
TGA Registered: Included in the ARTG as a Medical Class 1 Device in Australia (AUS).
ISO 13485 Certified: Certified for compliance with international standards for medical device quality management systems.
ISO 9001 Certified: Certified by Bureau Veritas for compliance with international quality management system standards.
CE Registered: Registered as a Medical Class 1 Device in the European Union (EU).
FDA Registered: Registered as a Medical Class 1 Device in the United States (USA).
Sport Protect Certified: Certified for use in sports, meeting safety regulations for athletes and rehabilitation programs.
These certifications reflect the commitment to maintaining the highest standards of safety, quality, and performance, making ANF Devices a trusted choice for healthcare professionals worldwide.