Valued customer

We are very pleased to announce that the following products are CE marked in conformity with the new European Medical Device Regulation (MDR, 2017/745).

  • FertiCultTM Mineral Oil
  • FertiCultTM High Viscosity Oil, as mineral oil variant with a significant higher viscosity

As summarized in our previous newsletter, CE marking according to the MDR does result in the following changes:

  • Use of 3-layered labels (For more information: see previous newsletter)
  • New version of instruction for use
  • Specific changes for FertiCultTM Mineral Oil
    • Viscosity specification is broadened to <60cP at 30 °C

If additional information is required or additional registration actions in your jurisdiction(s), please send your question to