Who we are

FertiPro 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 are located in a second building nearby.

FertiPro has been ISO-certified since 1999 acccording to the ISO9001 and ISO13485 (including CMDCAS) standards. Since October 2018 FertiPro is MDSAP certified for Australia, Brazil, Canada and the USA. In Januari 2011 a third building containing manufacturing and R&D laboratories was inaugurated!

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.

Latest news

Update IFU Spermac Stain and VitalScreen, MSDS EpiScreen Plus (18-FEB-2019)
The instructions for use of Spermac Stain and VitalScreen have been updated.

The changes are listed in detail in the two statements which can be downloaded below:
IFU update notification - Spermac Stain
IFU update notification - VitalScreen

Click here to visit the Spermac Stain product page and download the latest version of the instructions for use.
Click here to visit the VitalScreen product page and download the latest version of the instructions for use.

Furthermore, the MSDS of EpiScreen Plus was updated and now includes the update of the GMDN code.
Click here to visit the EpiScreen Plus product page and download the latest version of the MSDS.

FertiCult IVF medium CE marked! (21-DEC-2018)
We are proud to announce that FertiCult IVF medium has been approved by our Notified Body (DEKRA Certification – 0344) and is now CE-marked! FertiCult IVF medium is a bicarbonate buffered cell culture medium for fertilization by IVF or ICSI. The CE marked product does not contain insulin and the composition of this medium fulfills the needs of gametes in preparation of, and during fertilization.

The instructions for use and the MSDS of FertiCult IVF medium have been updated. Click here to visit the FertiCult IVF medium product page and download the latest version of the instructions for use or MSDS.

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