Celitron Medical Technologies Kft.
Celitron develops and manufactures advanced bio waste treatment and sterilization solutions for medical facilities, pharmaceutical companies and the agricultural industry. 400 medical waste treatment units deployed / 4000 steam sterilizers deployed / 70 countries worldwideOur product portfolio offers a complete solution for infection control and decontamination procedures in hospitals and dental clinics. With selected and tailor-made models for OEM partners and distributors in these sectors, Celitron has secured a stronghold in almost every continent by means of high quality service and strong delivery capacity. With its development and production site in Hungary and its global distribution network, Celitron delivers to clients all over the world – particularly in Europe, the Middle East, North Africa, and South America. The firm is currently entering other attractive markets such as Africa, Asia, and North America.
Celitronis a Hungarian (EU) manufacturing company withR&D focus on sterilization and bio waste treatment systems. We have an international presence, with more than400 deployed medical waste treatment unitsand over4000 deployed steam sterilizersin over70 countries worldwide.
Our product portfolio offers biological infectious waste treatment solutions in themedical, pharmaceutical and agricultural industriesand steam sterilizers, autoclaves for infection control and decontamination procedures in dental offices, clinics and hospitals.
Withselected and tailor-made models for OEM partnersand distributors in these sectors, Celitron has secured a stronghold in almost every continent by means ofhigh quality service and strong delivery capacity.
Celitron is committed to demonstrating excellence in all spheres of its work and in its interactions with customers, business partners, and suppliers. Celitron works with thebest suppliers throughout Hungary and Europe alike. We are committed to providing high-quality products and services to our customers and sustained profitability to our business partners, by investing in our employees’ skills. In this way we demonstrate our commitment toprofessionalism, perseverance, andteam spirit.
Celitron manufactures all its products, stocks spare parts and has offices at an 8898m² plant on a brand new industrial parklocated in Vác, Hungary(30 minutes from Budapest Airport). It is here that ideas become real. The company employs more than 80 full-time personnel, working closely together.
With itsdevelopment and production sitein Hungary and itsglobal distribution network, Celitron delivers to clients all over the world – particularly inAsia, Europe, the Middle East, North Africa, and South America. The firm is currently entering other exciting markets includingAfrica and North America.
Celitron is committed to leading through innovation andoutstanding product safety, efficiency, and performance. Our products are certified in accordance with the stipulations of the applicable directives, especially the Pressure Equipment Directive (97/23/CE) and the Medical Devices Directive (93/42/CE). In order to meet the most stringent requirements, we control, measure, and analyze all processes in our Quality Management Systemin accordance with international standards.
The company’s significant contribution to improvements made across the medical, pharmaceutical and agricultural fields is demonstrated by the quality of its products and services. As part of its quality policy, Celitron also makes the utmost efforts toprotect the environment.
Celitron intends to grow globally by developingnew solutionsfor the medical, pharmaceutical and agriculturalmarkets of tomorrow. The company’s strong innovative drive is based on its close relationships with its partners and the know-how of the research and development team, as well as the quality manufacturing of the Hungarian plant.
Our vision is to fulfill the market needs withturn-key solutions using only green technology.
In order to secure continuous improvement in its products and processes, Celitron Medical Technologies maintains aQuality Management System. In compliance with the international standards, the company measures, controls and analyzes all processes, and implements all necessary actions for achieving the required outputs.
We are committed to maintain the effectiveness of our Quality Management system, both by complying with our Customer’s requirements to their full satisfaction and by responding to the various requirements derived from standards and laws (and in particular, safety and performance regulations).
For this matter, the company identifies the training needs of all levels required by the personnel to perform their work. The company ensures that its employees receive appropriate training relevant for their position, and allocates resources to maintain and improve the products’ quality.
Celitron’s products comply with the following international standards and directive guidelines:
CE 2409 Approved by the Hungarian Notified Body CE Certiso Kft.
CE 1008 Approved by the Hungarian Notified Body TÜV Rheinland InterCert Kft.
General Applicable Directives:
Medical Device Directive (MDD) 93/42/EEC as amended (2007/47/EEC);
Pressure Equipment Directive – PED 97/23/EC;
Machinery Directive – 2006/42/EC;
2006/95/EC Low Voltage Equipment Directive;
EMC Directive 2004/108/EC Article 7 (1);
RoHS II Directive 2011/65/EU;
EN 13060:2004 + A1:2009 + A2:2010 – Small steam sterilizers;
EN 285:2006 + A2:2009 – Large steam sterilizers;
ISO 17665-1:2006 – Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices;
EN 60601-1:2006 + AC:2010 – Medical electrical equipment – General requirements for safety;
EN/IEC 61010-1:2010 – Safety requirement for electrical equipment for measurement, control, and laboratory use – General requirements;
EN 61010-2-040:2005 – Safety requirements for electrical equipment for measurement, control and laboratory use – Particular requirements for sterilizers and washer-disinfectors used to treat medical materials;
EN 60601-1-2:2007+AC:2010 – Medical electrical equipment – General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests;
EN 61326:1997 + A1(98) + A2(01) + A3(03) minimum immunity requirements; Class A – Electrical equipment for measurement, control and laboratory use – EMC – requirements;
EN/IEC 62366:2007 – Medical devices – Application of usability engineering to medical devices;
EN ISO 10993-1:2009 – Biological evaluation of medical devices – Evaluation and testing within a risk management process;
EN 1041:2008 – Information supplied by the manufacturer of medical devices;
EN ISO 15223-1:2012 – Medical devices – Symbols to be used with medical device labels, labelling and information to supplied – General requirements;
EN 60601-1-6:2010 – Medical electrical equipment – General requirements for basic safety and essential performance – Collateral standard: Usability;
47CFR part 15:2004, subpart B, Class A – Radio Frequency devices;
EN/IEC 60204-1:2005 + A1:2009 – Safety of machinery – Electrical equipment of machines – General requirements;
EN/IEC 61000-6-2:2005 – Electromagnetic compatibility (EMC) – Generic standards – Immunity for industrial environments;
EN/IEC 61000-6-4:2006 + A1:2011 – Electromagnetic compatibility (EMC) – Generic standards – Emission standard for industrial environments;
EN/IEC 61000-4-2:2008 – Electromagnetic compatibility (EMC) – Testing and measurement techniques – Electrostatic discharge immunity test;
Quality Management System Standards:
ISO 9001 – Quality Management Systems – Requirements;
ISO 13485 – Quality systems – Medical devices – Particular requirements for the application of ISO 9001;
EN ISO 14971:2012 – Risk Management for Medical device;