MediPurpose® News: 2004 Headlines

NORCROSS, Ga., Feb. 23—SurgiLance™, the designer and manufacturer of the One-Step Safety Lancet, has obtained approval for distribution within Europe. The line of SurgiLance One-Step Safety Lancets has now been qualified for distribution within the European Union (EU)—with the issuance of an endorsement of manufacturing quality called the CE Mark—on February 13, 2004.

As required by 18 countries within the EU marketplace, a company's product must conform to quality management regulations as set forth by the Medical Device Directive (MDD). Once endorsed by the MDD, a company is free to apply the CE Mark on the product itself or product packaging in order to allow access to the European Market.

The receipt of this marking assures consumers and distributors that SurgiLance is in full compliance with all applicable laws and regulations for the design, manufacture and distribution of medical devices within the EU. It allows for existing U.S. distributors to expand the sale of the SurgiLance™ One-Step line of safety lancets into the European marketplace. Additionally, OEM manufacturers are now free to sell SurgiLance products globally.

In January 2004, SurgiLance signed a distribution agreement with Frans Maas (UK) Ltd, a well-known major global player in freight forwarding and logistics. This facility will serve as the "hub" for the distribution of the SurgiLance™ One-Step Safety Lancet all across Europe.

The issuance of the CE Mark also comes on the heels of an overwhelmingly positive response this past year to the One-Step Safety Lancets at the 2003 Medica Conference in Dusseldorf, Germany.

In the time since the 2003 Medica conference, a steady stream of new inquiries has been filtering into SurgiLance's London office. SurgiLance representatives exchanged business cards with almost 300 individuals, representing more than 60 countries worldwide—some of them coming from as far away as Iceland, South Africa, Slovenia and New Zealand.

Vice President and head of the European division of SurgiLance Stephen Yi said, "the acquisition of the CE Mark now allows us to ship the One-Step to some of our customers who have been waiting anxiously for this clearance."

Ed. note: This release was published prior to MediPurpose™ changing its name from its prior company name—SurgiLance—in 2006.