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).

  • Sil-Select StockTM
  • Sil-Select PlusTM
  • GAINTM medium

As summarized in a 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 Sil-Select StockTM and Sil-Select PlusTM:
    • Sperm survival test (SST) is replaced by a human sperm survival assay (HSSA). This means no change in test method, but only a minor difference in calculation of results
    • Viscosity is omitted as specification
  • Specific changes for GAINTM medium
    • Additional product specification: human sperm survival assay(HSSA) (% motility compared with control after 24 hours exposure to test medium): ≥80%
    • Intended use does no longer include swim-up or density gradient preparation

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