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.
SpermFreeze SSP and Fructose Test IFU update + calculation sheet Fruct (17-NOV-2016)
The instructions for use for SpermFreeze SSP and the Fructose Test have been updated. For the SpermFreeze SSP the test protocol has not changed however. The instructions for use are translated in 5 languages and the instructions for use bear the CE mark now.
Click here to visit the SpermFreeze SSP product page and download the latest version of the instructions for use.
The instructions for use of the Fructose Test are updated with the remark that steps with Reagent 3 should be performed under a fume hood:
step 9: "Remark: perform step 10-13 under a fume hood as Reagent 3 is toxic by inhalation (see warnings and precautions)."
Warnings and precautions: "Reagent 3 (Indole in methanol): ...Always work under a fume hood when using this reagent."
Click here to visit the Fructose Test product page and download the latest version of the instructions for use.
To facilitate the calculation of the results of the Fructose Test, a calculation sheet is added to the website. This calculation sheet can also be downloaded on the Fructose Test product page.
Update Hyaluronidase in FertiCult Flushing medium instructions for use (19-JUL-2016)
The instructions for use for Hyaluronidase in FertiCult Flushing medium has been updated. The test protocol has not changed however.
Click here to visit the Hyaluronidase in FertiCult Flushing medium product page and download the latest version of the instructions for use.