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Fertipro N.V.: FDA-registered device maker in BEERNEM West-Vlaanderen, Belgium, 6 510(k) clearances

Name: Fertipro N.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fertipro N.V. is registered with the FDA (registration 3003272500) in BEERNEM West-Vlaanderen, Belgium. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003272500
Address: Industrie Park Noord 32, BEERNEM West-Vlaanderen, Belgium, 8730
Owner or operator: FERTIPRO N.V. (9046065)
Roles: Contract manufacturer, Manufacturer
First device listed: February 5, 2003
Registered through: 2026
Brand names listed: Assisted Reproduction Media, HOS Test, InActiv Blue, LeucoScreen Plus, Media Reproductive Exempt, Media, Reproductive, SpermMar Test IgA Complete kit 50 tests, SpermMar Test IgA Single kit 50 tests and more

Devices it lists

Device	Product code	Class	Role	Source
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Media, Reproductive	MQL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Media, Reproductive, Exempt	QKI	2	Manufacturer	accessdata.fda.gov
Microbial Nucleic Acid Storage And Stabilization Device	QBD	2	Manufacturer	accessdata.fda.gov
Reagent, Immunoassay, Igg	KTO	1	Manufacturer	accessdata.fda.gov
Stains, Chemical Solution	LED	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 30, 2025	K242640	FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin	MQL	Substantially Equivalent	Fertipro NV	accessdata.fda.gov
June 11, 2024	K221547	InActiv Blue	QBD	Substantially Equivalent	Fertipro NV	accessdata.fda.gov
August 16, 2007	K070135	VITRIFREEZE MEDIUM; VITRITHAW MEDIUM	MQL	Substantially Equivalent	Fertipro NV	accessdata.fda.gov
March 23, 2006	K053494	OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE	MQL	Substantially Equivalent	Fertipro NV	accessdata.fda.gov
June 8, 2000	K000989	SPERM WASH MEDIUM, CAT# 2003/2005	MQL	Substantially Equivalent	Invitrocare, Inc.	accessdata.fda.gov
May 4, 2000	K000939	HTF-HEPES	MQL	Substantially Equivalent	Invitrocare, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.