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: FertiCult Aspiration medium
FertiCult Aspiration medium is CE certified as a Class 3 medical device.
FertiCult Aspiration medium is a HEPES buffered medium that is used for oocyte retrieval. It contains 2.5IU/ml heparin to avoid the formation of blood clots in the pick-up needle and tubing.
Update Spermac stain instruction
The instructions for use for the Spermac Stain product have been updated. They now mention that it is best to use liquified semen to make the smear. This is logical but was not explicitely stated in previous versions of the instructions.