Overview

𝗖𝗔𝗧𝗘𝗛 Ltd. is a lead company based in Croatia - EU, specializing in the production of custom-made medical devices for a specific user with additive technologies -biocompatible surgical implants, registered as medical device manufacturers at HALMED (Agency for Medicinal Products and Medical Devices). Our medical products are: ★ molds for individual bone cement implants ★ 3D printed medical models of the patient for surgery planning ★ individual surgical guides for implant placement and positioning ★ individually designed implants to order 𝗖𝗔𝗧𝗘𝗛 Ltd. uses its own development and research, in collaboration with the world's leading manufacturers of additive manufacturing devices and manufacturers of materials for the same, and the application of new certified materials in medicine, and as a result of its own research has developed two families of medical products 𝟯𝗗𝗺𝗼𝗹𝗱𝗫™ individual bone cement implants and 𝗘𝗩𝗢𝗣𝗘𝗘𝗞™ individual implants from PEEK. 𝗖𝗔𝗧𝗘𝗛 Ltd. manufactures its custom-made medical products for a specific user with additive technologies in a clean space "Clean Room" designed according to the requirements for clean production and validated according to ISO 14644-1 and the EU GMP standard of purity class. The excellence we nurture for the application of additive technologies in medicine is applied by our team to all our other users in the field of technology and everyday life. Under the influence of market globalization, and in order to maintain and improve the market position and increase competitiveness, 𝗖𝗔𝗧𝗘𝗛 Ltd. strives for product and service excellence guided by customer requirements and expectations. An important basis for success in this direction are the implemented quality management systems ISO 9001: 2015 and ISO 13485: 2016, and we have harmonized everything according to the relevant provisions and directives prescribed for medical devices made to order according to MDR (EU) 2017/745.