Product Quality

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. U4U^® PRP tubes prevent blood clotting with the anticoagulant they contain. 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.

Patient Safety

Platelet-rich plasma is prepared under perfectly sterile conditions. Separation of plasma is only achieved by the physical properties of the tube. Some PRP tubes on the market contain gel. Although it is said that there is no allergen danger of the gel according to many studies, there is always this risk medically. U4U® PRP kit is produced for PRP only. It is designed in such a way that it does not create negative consequences for the human body.

Fast and Practical

An 8-minute centrifugation 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.

CE Class IIb 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 audit of approved organizations authorized by the ministries of health. For products that are deemed to be safe and meet the requirements as a result of the audits, an “EC certificate” is issued to the manufacturer together with the “CE Declaration”. Identification numbers of the notified bodies that auditing manufacturer 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.