Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036725842

FEI Number

3036725842

Entity Name

GYNOTEC B.V.

City/State/Country

Malden Gelderland, NL

Establishment Address

Rijksweg 150, Malden Gelderland 6581 ET, NL

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Gynotec B.V. (Owner Number: 10092680)

Owner / Operator Contact Address

Rijksweg 150, Malden, NL-GE 6581 ET, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053494

PMA Number

N/A

All Registered Proprietary Names

SpermWash USA SpermFilter SpermCryo All-round

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2026-01-13
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2025-02-05

Official Correspondent

Marlou van Beek - Berbers

US Agent Details

Kyle Rose Business: Rook Quality Systems Email: kyle.rose@rookqs.com Phone: (404) 7179358

Related Public Records

Same Entity

Gynotec B.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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036725842. Last updated year: 2026. Please use registration number 3036725842 when referencing this establishment in official correspondence.