FertiPro N.V. has been one of the leading manufacturers of diagnostics and cell culture media for use in assisted reproductive techniques and diagnosis of male infertility since 1992.
Production takes place in our overpressurized, controlled laboratory environment which is classified as GMP Class C. Aseptic processing and sterile filtration is done in a Class A environment. Part of the aseptic processing is done in a state-of-the-art, Class A isolator which is fully GMP compliant.Our production lab is part of the main company building. Administration services, packaging and shipping and R&D are located in a second building.
FertiPro has been ISO-certified since 1999 acccording to the ISO9001 and the ISO13485 (including CMDCAS) standards.
All our diagnostic kits are CE marked based on the European Directive for IVD's 98/79/EC. Most of our media products are CE marked according to the European Directive for Medical Devices 93/42/EEC.
Updated safety data sheets
The Material Safety Data Sheets for all the products have been updated to the latest European format and content requirements.
SpermMar IgA: 18 month shelf life
An update to the SpermMar IgA product design has led to an increased shelf life of 18 months instead of 12 months. The only noticable difference to the product is the fact that the beads that are used for the test are now brown instead of white.