Facialtech, an innovative craniofacial bone implant, owns Certificate of Free Sale. The certificate allows this implant to be sold in Poland.
Facialtech is based on the image of the patient’s computed tomography. Our engineers create a virtual model of the skull and then adapt the implant to the patient’s bone defects. Designing process provided by special computer program allows taking into account bone defects, cancer tumors or vascular pathologies occurring with a particular patient. The project also includes detailed indications of attending physician. Therefore, Facialtech fits perfectly like a jigsaw puzzle.
Certificate of Free Sale, given to Facialtech implant awarded by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products confirms that the product meets the requirements set out by the Act on Medical Devices, does not pose a threat to the health and life of patients and can also be placed on the Polish market.
This is further implant certified with a Free Sale Certificate designed in Individual Medical Implants Unit in Bionanopark. Craniotech® and Orbitech® implants, which enable perfect reconstruction of orbital and cranial bone defects, had this certificate since 2014. Individual medical implants allow us to eliminate vision disorder of patients who suffered orbital injuries (such patients often have diplopia). Moreover, they are a method of facial and cranial malformations removal or cranial bone loss replacement. So far, over 120 patients have been implanted. Our Unit is the only facility of its kind in Poland.