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What regulations or standards does The DivaCup™ have to meet?The DivaCup™ is approved by Health Canada and the FDA in the United States. It is also available for sale in many other countries around the world including any country in the European Union.Diva International Inc. is also ISO 13485 certified to meet the new medical device requirements of Health Canada as of January 1st, 2003. This certification ensures that The DivaCup™ is manufactured, packaged, and sold following specific procedures to ensure the highest quality, safety and effectiveness of the product. ISO 13485 is a Quality Standard governed by the International Organization of Standardization based out of Geneva, Switzerland, and is recognized and practised in over 160 countries around the world. ISO 13485 is the quality standard for medical devices which is designed to ensure that companies follow strict guidelines to ensure the highest quality of their products, as well as meeting applicable government requirements. |
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