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).

  • VitriFreeze™ / VitriThaw™
  • VitriFreeze ES™ / VitriThaw ES™
  • FertiVit™ Cooling / FertiVit™ Warming

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
  • Change of color of the caps: all cooling/freezing media will have blue caps.
    All warming/thawing media will have green caps
  • Specific changes for FertiVit™:
    • Volume of FertiVit™ Cooling 5 was increased from 1 ml » 1.5 ml
    • Volume of FertiVit™ Warming 1 was increased from 5 ml » 7.5 ml

If additional information is required or additional registration actions in your jurisdiction(s), please send your question to ra@fertipro.com