Ella-CS is purely domestic company, without any foreign ownership, yet our production is represented in almost 50 countries over the world and the number is still growing.
Research, developement, professionality
The success of ELLA-CS products indicates the reliability and exceptional quality of the manufacture. The company works steadily on the research and development of original health care devices to widen the therapeutic options of practitioners. The cooperation with leading specialists and practitioners is invaluable for successful research led by our company. So our products are submitted to rigorous examination in scientific publications and studies by renowned researchers from all over the world. The main intention of the company is to continue developing original products in close co-operation with the world most important clinical centers.
We would like to express our cordial thanks to all the physicians and specialists, who considerably contribute to the development and constant improvement of ELLA-CS products. We wish for our products to serve your patients in the best possible way.
Recently the company has mainly focused on the gastrointestinal stent production. Our portfolio includes esophageal stents, pyloroduodenal, biliary and colorectal stents. Our company is sole manufacturer of several globally unique health care devices.
ELLA-CS is the only producer of unique health care devices:
This stent is successfully used in treatment of esophageal, tracheal, biliary and intestinal illness, in the colon the biodegradable stent has been successfully used to treat the Crohn disease.
Danis stent is unique health care device developed for stopping of the acute variceal bleeding. By developing and manufacturing of this product the company ELLA-CS brought a revolutionary option for treatment of this severe condition. This way of treatment can be used in emergency situation, brings better comfort for the patient and allows the medical staff to perform further treatment easily.
Extractor is an original device for esophageal stents removal if the stent is not needed anymore. The Extractor design allows removal of nitinol esophageal stents manufactured by ELLA-CS without causing trauma to the esophageal wall.
For specific patients our company manufactures individual custom made devices. The production is based on the practitioner’s description. Frequently stents of non-standard dimensions are requested, but our company is competent to produce some of the most complicated implants as bone replacements for cranioplasty, implants for large bone defects reconstruction, maxilo-facial surgery, plastic surgery, etc.
History of health care devices production
In the past period the company portfolio included such products as peripheral non-vascular and vascular stents, prostatic spiral, implantable ports, ophthalmic implants, aortic stentgrafts and other standard products or custom-made devices. Some of these are still produced for certain customers.
The quality management system
The company established and maintains the quality management system in compliance with ISO 13485. 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 company received the first CE Certificate. Since January 1, 2007 EZU Praha (NB 1014) has become Notified Body for ELLA-CS; based on the EU legislation Council Directive 93/42/EEC on medical devices.
The audit (TUV) for obtaining ISO 9001, EN 46001 was successfully completed.
ELLA-CS was established concentrating on the production of specialized medical equipment. ELLA-CS came into existence as a logical continuation of production activity dating back to 1986.
Institute of Experimental Oncology of the Medical Faculty of Charles University in Hradec Kralove develops research in the field of special health care devices. In this year the first thermocouple probes for radiotherapy were developed in this institute.