6. What trials and safety tests have been undertaken?

Full clinical trials have taken place in Turkey. Following publication of the initial data, validation sources were used such as NHSBT. Full CE approval was granted for the medical device following initial assessments and positive trial outcomes showing no adverse responses to the filtration process. Additional indications for use are being sought for the CE certification for use in paediatrics. In addition to this, further developments to increase filtration options and properties are in full development.

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