Recently, the modular OXYSWING® PSA medical oxygen generators from IGS Italia reached another important milestone, after the Romanian Ministry of Health officially registered the innovative product as authorised medical devices, following an extensive internal verification.
The Romanian Ministry of Health has officially registered the product line as authorised medical devices according to its publication no. 92/2007 and the Governmental Decision no. 911/2005.
Oscar de Groen, Managing Director of IGS Italia, commented, “This important result not only will give our modular OXYSWING® PSA medical oxygen generators a strong market position in Romania, but will also have strategic value for our activities in other European countries. As a matter of fact, the modular OXYSWING® PSA medical oxygen generators have already been certified as Class IIB medical devices to the European directive 93/42/EC.”
“Only Class IIB certified medical oxygen generators are suitable for the oxygen supply to patients whose vital functions are directly and constantly depending on a higher oxygen concentration in the breathing air.”
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