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news release - gains european ce marking NEWS RELEASE
Visiomed gains European CE marking
Australia, 15 March 2006: Visiomed Group Ltd (ASX:VSG) is pleased to provide
the following update on recent progress related to expansion of the Company’s
Funhaler® incentive asthma spacer into overseas markets.
Visiomed gains European CE marking
Visiomed has been informed that it has compiled the necessary quality systems and
product technical documentation for CE marking, and as such has applied the CE
marking to the Funhaler®.
The European Commission describes CE Marking as a "Passport to Europe" which
allows manufacturers to freely circulate their products within the European market.
The letters 'CE' are an abbreviation of the French term "Conformité Européene", they
indicate that the manufacturer is compliant with all applicable EEC legal requirements
of the EU Directives. CE Marking is now mandatory for medical products sold within
the EU.
With application of CE Marking the Company's Funhaler now has free access for
sales within the 28 countries in the European Economic Area or EEA comprising:
Austria, Belgium, Denmark, United Kingdom, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, Cyprus, Czech
Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia, and Slovenia
plus Iceland, Liechtenstein, Norway, and Switzerland.
Visiomed has appointed UK-based Priory Analysts, specializing in Medical Devices
and European Regulatory Affairs, as the Company's European Authorized
Representative.
The Funhaler® asthma spacer is currently TGA registered in Australia and has
received US FDA clearance for sales into the United States.
Dr. William Dolphin, Visiomed’s Chief Executive Officer, said “Visiomed continues to
make great progress in operations, sales and marketing activities; the initiatives put
in place are yielding results as evidenced by the Company’s recently released half
year report showing a 20% increase in revenue and 40% decrease in losses over the
same period last year. The business is on track and the gaining of European CE
marking represents a significant milestone in the Company’s plans for expansion into
international markets. “