There are two elements of regulatory approvals. The first is that the device can be lawfully sold and meets these regulatory requirements. The second is if it is fit for purpose and meets the regulations regarding its claims for use.
As an IVD Device (Directive 98/79/EC), the Midstream has stringent regulatory requirements to meet in order to obtain its CE mark or FDA approval. The Midstream is registered with the Competent Authority of the Republic of Ireland since 2004 as an IVD device and is CE marked and FDA approved and it is sold throughout the world subject to the local registration laws of selling a medical product and any local language requirements for the instructions for use.
In regard to fit for purpose it is entirely fit for purpose to collect a midstream urine sample and does so based on published wide scale clinical trials better than any other known device for collection midstream urine samples. The results of the wide scale clinical trials above mentioned have indicated this; there is also the Centre for Evidence Based purchasing results (all downloadable) showing its significant cost benefits and cost saving per test.
Our Technical Specification Sheet gives a full specification of the device and the purchaser can make an objective decision. Please contact us to obtain a copy of the Technical Specification sheet for the Midstream.
