Finnish Standards
Genti-She menstrual cup is safe. It is made of medical-grade silicone which is FDA approved for medical use. The cup is manufactured in a Finnish factory that closely monitors the production of each product to guarantee the safety of the materials used. The production of every Genti-She menstrual cup can be tracked from the raw material to the finish product.
According to EU legislation, the menstrual cup isn't a product that is to be controlled by the National Agency for Medicines; however, regular consumer protection laws do apply. This is why the Genti-She menstrual cup isn't able to include any label indicating the approval of the national health authority in Finland. Gentis Bio-science products have received the Key Flag emblem, a certification by The Association for Finnish Work for first-class Finnish.
According to EU legislation, the menstrual cup isn't a product that is to be controlled by the National Agency for Medicines; however, regular consumer protection laws do apply. This is why the Genti-She menstrual cup isn't able to include any label indicating the approval of the national health authority in Finland. Gentis Bio-science products have received the Key Flag emblem, a certification by The Association for Finnish Work for first-class Finnish.
SA Standards- Genti-She Menstrual Cup is an SABS approved product.
Gentis has always laid utmost emphasis and efforts into implementation and uplifting the principles of Good Manufacturing Practices (GMP) as well as following Quality Systems in accordance with ISO 9001/EN ISO 13485. As a manufacturer of medical devices, the company is committed to provisions such as Council Directive 93/42/EEC and products in compliance with this Directive can be identified by the CE mark. All this is possilbe due to the commitment of the company personnel as every member understands and accepts the responsibility of producing GMP products that are 'safe for use and of the highest quality'.