FERTIPRO N.V.
FertiPro website
Who we are Founded in 1992, FertiPro is a reliable, independent manufacturer of in vitro diagnostics and cell culture media used in assisted reproductive technologies and the diagnosis of male infertility. State-of-the-art manufacturing Manufacturing takes place in FertiPro’s own, state-of-the-art, fully environmentally controlled, production facility in Beernem, Belgium. Product catalogue Our product catalogue can be downloaded here . It gives an overview of FertiPro’s complete product range. Certification and quality assurance 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 ei
- Type
- Manufacturer
- Location
- BEERNEM West-Vlaanderen, Belgium
- Website
- https://fertipro.com
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- facility-registered (green), checked 2026-08-17 US FDA device establishment registration (openFDA)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- debarment-clear (green), checked 2026-08-14 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-14 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-14 OpenSanctions
- fda-registered (green), checked 2026-08-14 FDA
- domain-registered (green), checked 2026-08-14 Domain registry record
Claimed certifications
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)