About us
TESTS & CHECKS

According to the European Council Directive 93/42/EEC concerning medical products, all medical products must be safe and compatible and reflect the latest science and technology. Manufacturers have to prove this to the so-called "notified bodies". The notified bodies check the quality management presented by the manufacturer. If all requirements are satisfied, the notified body provides the manufacturer with certification. The manufacturer documents this certification by printing the CE marking on their product or packaging. As condoms belong to a high medical device class - IIb - the number of the notified body must also be provided after the CE marking.

EN-ISO 4074 is the harmonised European standard for condoms. Condoms that meet this standard’s requirements also meet the fundamental requirements of the European Council Directive concerning medical products.
Manufacturers of medical products are reviewed by their notified body every year. During these checks, the manufacturer must demonstrate that their quality management system can meet the requirements for the medical device being certified. The EU certificate confirms that, in accordance with the European Council Directive concerning medical devices, Ritex has implemented and continues to apply the best possible quality assurance system for each phase from design to final product inspections.
 

Ritex condoms & lubricants stand out thanks to their excellent skin tolerance

When developing products and during the whole production process, Ritex takes utmost care in ensuring the products' compatibility with skin. In clinical trials, the skin compatibility of our condoms and lubricants was rated "very good" by an independent accredited institute. Further information on this can be requested from us free of charge.