Yes, SwimCount has as of 29th May 2015 been granted the CE certificate for sales in the entire European Union. The certificate is issued by The British Standards Institution. SwimCount has not yet been approved by the FDA for sales in USA - we expect this to happen later in 2015.
SwimCount has a sensitivity of 96% and specificity of 91%. This means that if the test shows that your sperm have more than 5 million motile sperm cells, it is 96% likely that the test result is correct. If the test shows that your sperm have less than 5 million motile sperm cells per ml., it is 91% likely that the result is correct.
No, the result may change if left too long. So, you need to take pictures for documentation after 30 min. Specified in the instructions for use.