ENKI is a new company, set up in 2002, aimed at supplying Customized Products in different fields: • Biomedical • Eletronic • Chemical • Automotive • Aerospace • Pharmaceutical Although in recent years we have specialized in the Biomedical field in the following fields: • Radiofrequency • Epiduroscopy • Tracheostomy • Gynecology • Epiduroscopy • Tracheostomy • Assisted fertilization • Radiology • Vascular • Neurosurgery • Endoscopy and Laparoscopy ENKI is the ideal structure for the development of prototypes, customized devices, medical devices in Class 1 (sterile and non sterile), 2A, 2B e 3. According to annex IX of European Directive 93/42/CEE and following reviews. Flexibility and organization allow us to support our customers through the different steps, from prototyping, also rapid prototyping, until production in Class 10.000 ISO 6 – ISO 7 – ISO 8 Clean Rooms. ENKI is always ready to face New Challenges and develop the most cutting edge projects. ENKI has a long lasting experience in the Design and Development of Disposable Medical Devices, in particular Catheters. ENKI manufacture Microtubes, braided tubes and Customized Profiles with Tri-and four layer Extrusion lines and in the Moulding department with small moulding machines, Enki can manufacture customized Micro-Components according to the customer’s needs Everything is manufactured in Class 10.000 ISO 6 – ISO 7 – ISO 8 Clean Rooms. ENKI has a Clean Room that is entirely dedicated to Balloons prototyping and manufacturing in different shapes, dimensions and materials. ENKI is The Only Worldwide Manufacturer and Patent holder KI-BEAM ® of plastic thin-walled capillary tubes, with excellent X-rays transparency. ENKI exceedes in: • engineering (FEA), prototyping and manufacturing of medical devices, acting as a contract manufacturer • balloons manufacturing (soft and rigid); • catheter prototypes development: - of every type - also in small quantities • production of tubes and profiles already existing or developed and/or to be improved - by inspecting critical aspects in production and construction specifications; • research and selection of components and accessories to be assembled to extruded tubes and profiles; • precision micro-components moulding. DESIGNING, PROTOTYPING AND MANUFACTURING Comply with UNI EN ISO 9001:2008 UNI EN ISO 13485:2004 ENKI offers his customers qualified assistance concerning the technical file documentation to obtain the CE marking approval on his product. This is done according to the European Council directives. Microtubes Microtubes Microballoon Microballoon Microcatheters Microcatheters Microcomponents Microcomponents KI–BEAM ®KI–BEAM ®Used Materials Used MaterialsISO CertificatesISO Certificates