... what does the law say?
the legislation provides that urine containers, as IVDs, must be CE marked;
to obtain the CE mark, for each device must be defined and declared the destination and the mode of use, and a consequent risk analysis must be performed;
a urine device placed on the market empty , then filled with a liquid (eg muriatic acid) by the patient, maybe following the indication of the lab, changes its purpose and method of use, no longer in accordance with what is declared, it ceases to be validly marked CE and the responsibility, in case of damages to the patient or to third parties, falls on those who have defined and indicated the procedure (the lab, the health facility and its managers…);
We have designed a totally safe urine collection device:
• the container is already supplied partially pre-filled with the solution to be added to the urine;
• the patient can add the urine, one or more times, in varying amounts depending on the lab examination and needs
but
• the liquid of which the container is partially pre-filled and the urine after its addition to the container cannot in any way leak out!
• the patient cannot drink it, splash it, inhale it, get dirty ...
• perfect compliance with regulations, no liabilities for improper use!
urinasafe™, in fact, is internally equipped with a unidirectional device that allows the addition of urine but not contact with the liquid.
The patient cannot drink it, splash it, inhale it, get dirty ...
The device also complies with all legal and related requirements
affixing the CE mark.
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