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

LeucoScreen Plus, renewal certificates, update IFU SpermMar, MSDS IVDs (11-OCT-2018)

*new* LeucoScreen Plus
LeucoScreen Plus is an improved histochemical staining kit for the determination of peroxidase-positive white blood cells in semen. LeucoScreen Plus has an equal capability to distinguish between peroxidase-positive and -negative round cells as the LeucoScreen kit (same assay performance), but has the advantage that the substrate is not carcinogenic.
Click here to visit the LeucoScreen Plus product page, watch the instruction video and download the instructions for use, MSDS and excel training file.

Renewal quality management certificates and CE certificates
FertiPro’s quality management certificates (ISO 13485:2016, ISO 9001:2015 and MDSAP) and CE certificates have been renewed! Click here to download the ISO 9001/ISO 13485 certificate and ISO 13485 MDSAP certificates. CE certificates are available upon request.

Update IFU SpermMar Test IgG/IgA
The IFU of SpermMar Test IgG/IgA has been updated. What has changed? The SpermMar Test IgG Negative Control should yield less than 40% spermatozoa covered with latex particles instead of 20% or less spermatozoa covered with latex particles. This change is in line with the stated positive cut-off value of 40%. Furthermore, some other minor changes have been made to the text in the IFU.
Click here or here to visit the SpermMar Test IgG or SpermMar Test IgA product page and download the latest version of the instructions for use.

Update Material Safety Datasheets (MSDS) of IVDs
The MSDSs of SpermMar Test IgG, SpermMar Test IgA, Citric Acid Test, Fructose Test, Spermac Stain, LeucoScreen, VitalScreen, HOS Test and FertilitySCORE have been adapted to include an update of the GMDN codes. The MSDSs can be found per product page on our website.

Update IFU LeucoScreen and SpermMar Test IgG/IgA (10-SEP-2018)
The instructions for use of LeucoScreen and SpermMar Test IgA and IgG have been updated.

The update of the instructions for use of LeucoScreen includes a small change with a new barcode for the product demonstration video and the addition of a calculation method for samples with undetermined total round cell concentration.
Click here to visit the LeucoScreen product page and download the latest version of the instructions for use.

The update of the instructions for use of SpermMar Test IgA/IgG is the addition of the barcode to view the product demonstration video. Further cervical mucus is omitted as a specimen type from the IFU of SpermMar Test IgG.
Click here or here to visit the SpermMar Test IgG or SpermMar Test IgA product page and download the latest version of the instructions for use.

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Click on the link below to request a certificate of analysis, or to send feedback to FertiPro N.V.