Oxywise oxygen generators certified as medical devices.

Oxywise oxygen generator well known for outstanding quality and reliability, is fully certified for the healtcare market.

medical device directive oxygen generator

Oxywise medical oxygen generators has been successfully certified as medical devices according to medical device directive (MDD 93/42/EEC), class IIb.

Apart from MDD approval, Oxywise quality management system is certified according to both ISO 9001:2008 and ISO 13485:2012 for the design and development, sales, production and installation, service and maintenace of medical oxygen generating systems.