FertiPro

FertiPro is an ISO13485 certified company, that participates in the MDSAP program. FertiPro has product registrations in Europe, Canada, United States of America and in increasingly more countries worldwide. All of the diagnostic kits and ART media are CE marked either as in vitro diagnostics or as medical devices. Certificates of analysis for all products are available upon request.

From the manufacturer's own website. Source

FertiPro manufactures diagnostic reagents and media for reproductive health, including sperm staining solutions (Spermac Stain A, B, and C), sperm analysis kits (SpermMar Test IgG and IgA), and culture media for assisted reproductive technology (FertiCult High Viscosity Oil, Sil-Select Plus). The company also produces reagents for sperm vitality and epithelial cell screening (VitalScreen, EpiScreen Plus) and devices for sperm preparation (Floater, Insert).

The portfolio includes devices classified as Class A, B, I, IIa, and III under EU regulations, with all relevant products listed in the EUDAMED database. FertiPro’s products are authorised as either in vitro diagnostics or medical devices, adhering to regulatory frameworks in Europe, Canada, and the United States. The company is headquartered in Belgium.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.