О нас

История

ELLA-CS was established in 1991, concentrating on the production of specialized medical equipment. The company is purely domestic, without any foreign ownership. ELLA-CS came into existence as a logical continuation of production activity dating back to 1986. This was under the auspices of the Medical Faculty of Charles University, Institute of Experimental Oncology in Hradec Kralove.

The beginning of export activities, with special thermocouple probes for radiothermotherapy, began in 1986. The thermocouple probes were developed in the above mentioned institute.
The company significantly expanded its portfolio with new products such as peripheral non-vascular and vascular stents, extractor of gastrointestinal stents, prostatic spiral, implantable ports, ophthalmic implants, aortic stentgrafts and other mass-produced or custom-made devices. The core business is development of original products in close cooperation with eminent clinical centers.

The company established and maintains the quality management system in compliance with ISO 14985. It operates clean room facilities with equipment ensuring the air cleanliness classified by ISO 14644 as ISO Class 7. The manufacture meets all principles of good practice as they are established by international, European and Czech standards.

The audit (TUV) for obtaining ISO 9001, EN 46001 and the first CE Mark certificate was successfully completed in 1996. Since 1st January 2007, EZU Praha (NB 1014) has become Notified Body and Competent Authority for ELLA-CS; based on the EU legislation Council Directive 93/42/EEC on medical devices.