May 25, 2010

CE certificate for concentrated hemodialysis solutions and x—ray films

For the first time Alkaloid AD Skopje acquired the CE Certificate for production of concentrated hemodialysis solutions.

The certification was approved by the renowned agency KEMA Quality B.V, a subsidiary of DEKRA Group from the Netherlands, one of the biggest certification agencies in the world. The authority, knowledge and services of KEMA Quality B.V confirm the quality of medical products.

The CE Certificate (CEMARKING OF CONFORMITY) was issued to Alkaloid AD Skopje, the producer from the Republic of Macedonia following an inspection performed by KEMA Quality B. This certification verifies that the products are in compliance with the European directives (Annex III, V, of the MDD 93/42/EEC and amendment 2007/47/EC), which guarantee safety, quality and efficiency of medical devices.

With this certification Alkaloid AD Skopje was granted the right to sell its products on hemodialysis on all markets in Europe.

CE Certificate for X-Ray film products was also renewed.