FertiPro N.V. is 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 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 instructions for use (14-AUG-2015)
The instructions for use of the below products have been updated recently:
CE mark: Hyaluronidase solution (11-JUN-2015)
Hyaluronidase in FertiCult Flushing medium is CE marked as a Class 3 medical device.
Hyaluronidase in FertiCult Flushing medium is a HEPES buffered medium that is used for removing cumulus cells after oocyte pick-up.