Certified Quality

EUROSETS has a Quality certified System ISO 13485 by TÜV Product Service GmbH of Munich and is registered as “Production company” of medical devices by the Italian Minister of Health. All the Eurosets’ products have the CE mark according with European directive MDD 93/42/EEC, in Italy granted with DL n. 46 of 24/02/1997. The Production is carried out completely in Clean Rooms ISO Class 8 according with EN ISO 14644-1.


Full Quality Management SystemISO 13485 Certificate

Design and development, production and distribution of medical devices and components for transfusion, auto-transfusion, filtration, drainage, washing, vacuum generators, circuits and components for extracorporeal and infusional circulation, blood oxygenating devices for extracorporeal circulation, wound therapy and blood monitoring systems for the main parameters of extracorporeal circulation.
Moulding of plastic components for medical devices.

EC Certificate G2 16 04 24169 032

Extracorporeal life support and E.C.M.O. tubing sets.
This medical devices may contain the components as listed in the attachment.

EC Certificate G2 16 04 24169 033

Blood oxygenating devices for extracorporeal circulation provided with cardiotomy reservoir for blood reduction of leucocytes and lipids and related circuits. Extracorporeal blood circuits with haemoconcentrators.

EC Certificate G2 16 04 24169 034

Negative pressure wound therapy disposable devices. Negative pressure wound therapy vacuum generator. Blood monitoring unit for the main parameters of Extra Corporeal Circulation.

EC Certificate G2 16 04 24169 035

Medical devices for transfusion (Micro-aggregates filters), Autotransfusion (Intra-operative and post-operative reservoir, Vacuum reducer, Anticoagulant and aspiration lines, Post-operative Autotransfusion systems), Drainage (Cardio-thoracic drainage systems, wound drainage systems with suction), Washing (Wound Washing, aspiration and cleaning systems, Pressure reducer), Vacuum Generators (for autotransfusion and post-operative drainage, wound drainage with suction), blood oxygenating devices for extracorporeal circulation (Oxygenators, venous Reservoirs and Cardiotomy), Circuits and components for extracorporeal and infusional circulation (blood circuits with or without oxygenators, reservoirs, centrifugal blood pump, connector for transducer for flow monitoring systems; cardioplegia and infusional circuits with or without heat exchanger; Connectors, Gas filters, Pre by-pass filters, cardioplegia and infusional solution filters, heat exchangers, Vascular tourniquet, one way valves; arterial filters).

EC Certificate G2 16 04 24169 036

Autotransfusion systems, blood processing (red blood cell concentration optical sensor, electromechanical clamp).