Our manufacturing facility is located in Snagov, in the neighborhood of Bucharest.
Lying on 1,400 sqm of built area, including production plant, warehouses, and offices, the unit in Snagov uses latest generation technology and the production area complies with SR EN ISO 14644-1:2002 international standard referring to clean rooms and associated controlled environments. According to this standard, production areas classify at ISO Class 8, and according to the American standard FDA-US 209 E, they classify under Class D – Clean rooms.
A clean room is a production area controlled in terms of air filtering and ventilating system, which provides constant concentration of particles inside the clean rooms and reduces particle generation by keeping them inside and maintaining constant parameters such as air temperature, humidity, pressure and purity.
Through this renowned and ample procedure we comply with the European regulations that refer specifically to the production of medical devices, therefore allowing us to produce and deliver superior quality medical devices at a more reasonable cost.