ConceptoMed today announced that the company has received CE Mark approval for the Luer-Jack® syringe, a new and innovative medical syringe. Luer-Jack® is now ready for the European market and other large markets, where the CE mark allows for market entry.
“Receiving the CE mark for Luer-Jack® follows a substantial company effort to safeguard all processes related to putting a Medical Device syringe on the market. The CE mark represents another very important milestone for ConceptoMed. We look forward to shipping the first orders of Luer-Jack® to our distributors. The company is now applying for an FDA approval to open up the vast potential in the US market”, said CEO M.D. Christian Mide.
In September and October 2015, ConceptoMed announced Luer-Jack® distribution agreements for the United Kingdom, Norway and 9 other countries, and are looking forward to announcing new international distribution agreements in the near future.
Luer-Jack® will become an important contribution in the struggle for improving procedure quality and safety, as well as ensuring aseptic procedures when handling syringes and needles – thus reducing probability of human error during the disconnection. Current syringes and needles on the market are delivered sterile, in very simple packaging – and it is not obvious that the method of opening the package safeguards sterility during actual use in patient treatment.
A key element of the next-generation medical syringe Luer-Jack® is the development away from using two hands during disconnections. Health authorities and medical professionals now have the option of using medical disposables with integrated safety logic – both on the medical device itself, as well as the package design.