Solos Endoscopy, Inc. (Solos) announced that the company has taken the initial steps to obtain the CE Mark for its Food and Drug Administration (FDA) approved MammoView line of surgical endoscopy instruments. This will allow the MammoView line to be sold throughout the European Economic Union (EEU).
The entire Solos Endoscopy product line has already received FDA approval for sale within the US and the company is now working diligently to capture market share within the EEU.
Solos Endoscopy is working closely with its manufacturers to ensure all requirements of the Medical Devices Directive (MDD 93/42/EEC) are met. The company is familiar with the steps that are to be taken to obtain the CE Mark for its MammoView line of surgical endoscopy instruments, as all of the company’s other medical devices have already obtained the CE Mark. Solos Endoscopy is currently in discussions with several companies, to act as its Authorized Representatives (EC REP) to liaison with its targeted European markets.
“Expanding into the EEU provides unlimited sales opportunities for Solos Endoscopy and our goal is to commence sales, within several European countries, in 2010,” stated Bob Segersten, President of Solos Endoscopy, Inc.
Solos is a developer and marketer of breakthrough technology, applications, medical devices, and procedural techniques for the screening, diagnosis, treatment and management of medical conditions.