[The National Institute of Public Health].

DOCUMENTS SUBMITTED: Certificate of the company IQNet and CQS No. CZ-2161/2006 for the silicone materials used for the menstrual cup production of the company Silroc CZ, a.s. of 19 June 2006. Specification of the silicone material Elastosil LR 3003 A, B from the producer, the company Wacker Silikones (Germany). Technical drawings B-2235 and B-2236 for the menstrual cups with the diameter of 40 and 46 mm were given in the documentation to the file of the Centre of Health and Life Conditions CZŽP 13-1184/08-156 dated 3 July 2008. Certificates of the company Bioservice Scientific Laboratories GmbH (Munich) for biological tests of the silicone material Elastosil LR 3003 A, B dated 10 July 1998 and 28 December 1998. Results of the microbiological tests of the material Elastosil LR 3003/ 30-70 shore A of 23 February 2004. Instructions for use of the menstrual cup. Opinion of CZŽP (the Centre of Health and Life Conditions) 13-246/08-36, EX 080221 dated 12 March 2008 for the LadyCup menstrual cup of colourless silicone and CZŽP 13-1184/08-156, EX 080850 dated 3 July 2008 for the LadyCup menstrual cup of silicone in the pink design PinkCup.