Vigmed receives CE-marking and ISO-certificate for IV-cannulae
Vigmed’s IV-cannulae now have the necessary pre-requisites to start the sales process in European markets having received CE-marking and ISO-certification, effective May 31 2013. This is in line with the plan presented prior to listing on Nasdaq OMX First North.
Vigmed has chosen to establish a close collaboration with MBH-International A/S (MBH) in Denmark as part of the process of creating a cost- and capital efficient organisation. For an initial period of a few years MBH will take on the full responsibility for Vigmed’s delivery chain, from the point where products leave the factory to the distributor for each of the markets within Europe. As a part of this commitment, MBH International A/S shall apply for and handle all the certificates necessary for Vigmed’s products in order to allow them to be sold within the EU. This is outlined in the company description that was released in the process of listing Vigmed on Nasdaq OMX First North earlier this year.
MBH International A/S have informed Vigmed, that from May 31 2013, MBH have had their quality system audited and approved by the licensing organisation (DGM Denmark A/S) and received CE- approval and ISO 13485
certification for sales of IV-cannulae in the European market. This means that Vigmed now has the formal approvals required to sell IV-cannula in the EU.
Vigmeds CEO Finn Ketler comments: “the fact that Vigmed has now received both its CE- and ISO certificate is an important step in the development of the company towards establishing itself as a serious and significant actor on the European market for safety cannulae. In parallel, the preparations are on-going for full-scale production and this work is on schedule. This means that by the end-of-the year we expect to have our first products on the market, something that is anticipated with great interest from both prospective users and distributors of our safe and efficient products”.
For additional information, contact:
Chairman of the board Lennart Holm (+46 70 630 8562) or CEO Finn Ketler (+45 21 54 6408), E-mail: fk@vigmed.com
Vigmed is a Swedish medical device company with the goal to offer the market unique needlestick protected devices for injection, infusion and blood sampling. Vigmed is headquartered in Helsingborg, Sweden, and has for the moment approximately 10 employees. Vigmed’s share is traded on NASDAQ OMX First North in Stockholm (ticker VIG) and has approximately 5 400 shareholders. Remium Nordic AB is the Companys Certified Advisor. Additional information such as company description, a video presentation and risk factors can be found on Vigmed’s home page: www.vigmed.com