U4U® 1 Set PRP kit
U4U® PRP kits have been developed to obtain the highest dose and get the best results in your applications. U4U® PRP tubes are specially designed and manufactured to high quality standards to achieve the most advanced high-density platelet count. Thanks to the anticoagulants they contain, they prevent blood clotting. U4U® PRP kits are Class IIb medical devices. It is a complete PRP kit approved with CE Certificate. Requires a single centrifugation operation. It minimizes the risk of contamination with its closed system.
Platelet-rich plasma is prepared under perfectly sterile conditions. Separation of plasma is only achieved by the physical properties of the tube. The U4U® PRP kit is made for PRP only. It is designed in such a way that it does not create negative consequences for the human body.
Fast and Practical
A gentle centrifugation for 8 minutes is sufficient to separate the platelets. Three phases appear: plasma, platelet concentrate, red blood cells. Buffy coat can be collected alone or in suspension with plasma by turning the lower chamber counterclockwise.
Class IIb CE Certificate
Currently, the legislation valid in the European Union regarding the products put on the market in Turkey has been included in the laws of our country and is being implemented.
The CE marking is mandatory for diagnostic and therapeutic products and indicates that the safety and performance of the products they are used in are checked in accordance with the current rules/standards before they are put on the market. No medical device without CE mark can be placed on the market.
As the product risk group rises, these controls are not just left to the producers; Both products and manufacturers are subject to the inspection of approved organizations authorized by the ministries of health. For products that are deemed to be safe and meet the minimum requirements as a result of the inspections, the “CE Declaration” of the manufacturer is issued together with the “EC certificate”. Identification numbers of the notified bodies that inspect it are also added next to the CE mark on the product.
PRP kits are classified as Class IIb medical devices by current regulations. Class IIb medical devices are the devices with the highest risk group (after Class III devices). For this reason, the package of U4U® PRP kits includes the number of the organization approved/authorized by the Ministry of Health next to the CE mark.
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