Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043478

FEI Number

3003474731

Entity Name

GYNETICS MEDICAL PRODUCTS NV

City/State/Country

Lommel Limburg, BE

Establishment Address

Rembert Dodoensstraat 51, Lommel Limburg 3920, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gynetics Medical Products (Owner Number: 9001946)

Owner / Operator Contact Address

Rembert Dodoensstraat 51, --, Lommel, BE-NOTA 3920, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K013497

PMA Number

N/A

All Registered Proprietary Names

Echosampler Delphin Semtrac Emtrac IUI Seminor Smooze FAS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HFF	Aspirator, Endometrial	Obstetrics/Gynecology	Class 2	884.1060	2007-11-30
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2007-11-30
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2007-11-30
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2007-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

Shawn Riedel Business: Nexpring Health Email: ksnjbusiness@gmail.com Phone: (303) 5123620

Related Public Records

Same Entity

Gynetics Medical Products

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
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06

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3005987240	ALLWIN MEDICAL DEVICES, INC.	ANAHEIM, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043478. Last updated year: 2026. Please use registration number 8043478 when referencing this establishment in official correspondence.