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.
CE mark for the PVP solution
We are happy to announce that we have received the CE mark for the 10% PVP solution in FertiCult Flushing medium. The product is classified as a Class 3 medical device.
Shelf life EmbryoFreeze/Thaw
The shelf life of EmbryoFreeze and EmbryoThaw have been extended from 12 months to 18 months.