We are very pleased to announce that the following product is CE marked in conformity with the new European Medical Device Regulation (MDR, 2017/745).
- Hyaluronidase in FertiCultTM Flushing mediumTM
CE marking of the product 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
- Endotoxin criterium is narrowed form <1 EU/ml to <0.5 EU/ml
- Carboard box as secondary packaging of product code HYA001
If additional information is required or additional registration actions in your jurisdiction(s), please send your question to email@example.com
In addition to the above
we hereby inform you that the color of the screw cap of 10% PVP in FertiCult Flushing in chromacols, i.e. product code PVP0.2S has changed from white to blue. This change does not have any impact on the performance and safety of the product.