TSO3 new sterilizer system gets European okay

TSO3’s (TSX:TOS) new sterilization system was cleared for sale in Europe after meeting the European Union’s new medical device directive for Class IIb medical devices, allowing TSO3 to label its product with the CE mark.

“We are pleased that a review of our quality system, electromechanical design and microbiological data, has been independently validated as meeting the new medical device directive (M5),” CEO Richard M. (Ric) Rumble said in a statement.

“Our new sterilizer is among the first to comply with this enhanced mandatory standard, a requirement all sterilizer manufacturers will need to meet.”

The device has now been approved in Canada and Europe, with U.S. regulatory clearance currently under review.  It will be distributed by 3M (NYSE:MMM) worldwide under the 3M Optreoz brand.