ISO 13485 Certified Vacuum Bells

We have worked with 

TÜV Rheinland, a German-based, internationally recognised testing body and attained an EN ISO 13485 certification for medical devices.

What does this mean for you? EN ISO 13485 is the international standard for quality management systems for medical devices. Our Vacuum Bells have been through rigorous testing, ensuring quality and safety. When you buy a vacuum bell through us, know you are only getting the best. 

We have certified for the regulations of the following organisations through the MDSAP.

Australia: The Therapeutics Goods Administration – TGA
Brazil: The Brazilian National Health Surveillance Agency - ANVISA
Canada: Health Canada - CMDCAS
United States: U.S. Food and Drug Administration’s Center for Devices and Radiological Health
Japan: The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA)