urinasafe™

 the safe urine collection


at home urine collection...

Often, for the execution of various lab urine tests, it is required that the patient collects the urine using partially pre-filled containers with preservative, acidifying or other liquids.

Normal pre-filled containers provided by lab analysis or available on the market have some critical issues:

• the patient, who is not a professional operator, is directly exposed to the liquid present in the container, which often has toxic, irritating, scalding, corrosive or other action; 

• the patient may not understand any danger symbols on the container;   

• and, in any case, handling the container, the patient may splash with the liquid, inhale the vapors, accidentally bring the dirty hands to the mouth ...

and it gets worse ...

• a child, finding the container at home, could easily open it and swallow the liquid it contains;

• even, for some tests, such as the collection of 24-hour acidified urine, it is an established practice of the labs to ask the patient to buy the muriatic acid and to pour it into an empty urine container, then to collect the urine, thus amplifying the risks;

 • labs, health facilities and IVD manufacturers could be subject to liabilities and legal actions in case of damages caused by the use of such devices! 

... what does the law say?

Mobirise

also ... the CE mark!

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…); 

urinasafe™, our proposal

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.

For our innovative technology, we have already been granted a patent utility model and the evaluation of a further patent application for industrial invention is underway.


nico innovagroup S.r.l.
limited liability company with a single shareholder

start-up company established pursuant to art. 4 paragraph 10 bis D.L. 24 January 2015, n. 3
registered in the special section as an innovative start-up

P.IVA e C.F.: 04020680981
REA: BS 582111
PEC: nicoinnovagroup@pec.it
 
Via Caleppe 6, 25125 Brescia, Italy  
info@nicoinnovagroup.com 

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