Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003272500

FEI Number

3003272500

Entity Name

FERTIPRO N.V.

City/State/Country

BEERNEM West-Vlaanderen, BE

Establishment Address

INDUSTRIE PARK NOORD 32, BEERNEM West-Vlaanderen 8730, BE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FERTIPRO N.V. (Owner Number: 9046065)

Owner / Operator Contact Address

INDUSTRIE PARK NOORD 32, BEERNEM, WEST-VLAANDEREN, BE-NOTA 8730, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SpermMar Test IgG Complete kit 50 tests SpermMar Test IgG Negative control SpermMar Test IgG Single kit 50 tests SpermMar Test IgA Complete kit 50 tests SpermMar Test IgA Single kit 50 tests SpermMar Test IgG Positive control Assisted Reproduction Media HOS Test Media, Reproductive InActiv Blue VitalScreen Spermac Stain LeucoScreen Plus Media, Reproductive Media, Reproductive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KTO	Reagent, Immunoassay, Igg	Immunology	Class 1	866.5530	2008-06-18
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2025-12-08
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2021-02-15
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2016-12-19
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	Class 2	866.2950	2024-08-09
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2008-06-18
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2003-02-05
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2016-12-19
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-07-16

Official Correspondent

Liesbeth Faes

US Agent Details

Tyler Ting Business: Rook Quality Systems Email: tyler.ting@rookqs.com Phone: (770) 8330116

Related Public Records

Same Entity

FERTIPRO N.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

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3036725842	GYNOTEC B.V.	Malden Gelderland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003272500. Last updated year: 2026. Please use registration number 3003272500 when referencing this establishment in official correspondence.