ELLA-CS is a purely domestic company, without any foreign ownership, yet our production is represented in more than 70 countries over the world and our distribution network is still growing.
Research, development, professionality
The success of ELLA-CS products indicates reliability and exceptional quality of manufacture. The company works steadily on research and development of original health care devices to widen therapeutic options for practitioners. Cooperation with leading specialists and practitioners is extremely valuable 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 cooperation with the most important clinical centers of the world.
Recently the company has mainly focused on the gastrointestinal stent production. Our portfolio includes esophageal, pyloroduodenal, biliary and colorectal stents. Our company is sole manufacturer of several globally unique health care devices.
ELLA-CS is an exclusive producer of the following 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’s disease.
Danis stent is a unique health care device developed for stopping of acute variceal bleeding. By developing and manufacturing of this product the company ELLA-CS brought a revolutionary solution for treatment of this critical condition. This way of treatment can be used in emergency situation, brings better comfort to the patient and allows medical staff to perform further treatment more easily.
Extractor is an original device for removing of esophageal stents if necessary. The Extractor design allows removal of nitinol esophageal stents manufactured by ELLA-CS without causing trauma to the esophageal wall.
For selected patients our company manufactures customized devices. The production is based on the medical practitioner’s written prescription. Frequently stents of non-standard dimensions are requested. Up to that our company is also competent to produce most complicated implants as bone replacements for cranioplasty, implants for reconstruction of large bone defects, implants for maxilo-facial surgery, plastic surgery, etc.
History of health care devices production
In the past period the company portfolio included products like peripheral non-vascular and vascular stents, prostatic spirals, implantable ports, ophthalmic implants, aortic stentgrafts and other standard products or custom-made devices. Some of these are still produced for our customers.
The quality management system
The company established and maintains the quality management system in compliance with EN ISO 13485. It operates clean room facilities with equipment ensuring the air cleanliness classified by EN 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 transformation of the company from a physical person to a legal entity with the name ELLA-CS, s.r.o.
Since 2007 is ELLA-CS under the supervision of the Notified Body EZU Praha (NB 1014) in accordance with European legislation and Council Directive 93/42/EEC concerning medical devices.
CE mark for esophageal BD stent was approved
CE mark for Danis stent was approved
The company received the first CE Certificate.
The audit (TÜV) 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 Králové developed research in the field of special health care devices. In this year the first thermocouple probes for radiotherapy were developed in this institute.