Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013530345

FEI Number

3013530345

Entity Name

MED PRO MEDICAL B.V

City/State/Country

Veenendaal Utrecht, NL

Establishment Address

Vendelier 45 E, Veenendaal Utrecht 3905PC, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MED pro Medical B.V (Owner Number: 10053600)

Owner / Operator Contact Address

Vendelier 45 E, Veenendaal, NL-UT 3905PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180354

PMA Number

N/A

All Registered Proprietary Names

Meatal Dilator Meatal Dilator Stone Basket UroGen Ureteral Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-09-19
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2025-09-19
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2017-11-07
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2016-12-21
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2019-06-27
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2019-06-26

Official Correspondent

Andre ten Brinke

US Agent Details

Alex Ebner Business: Ebner Medical Email: alex@acemedicalco.com Phone: (800) 4970851

Related Public Records

Same Entity

MED pro Medical 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
K033719	C.R. Bard, Inc.	BARD TIGERTAIL URETERAL CATHETER	2004-02-04
K820239	American Endoscopy, Inc.	RETRIEVAL FORCEPS	1982-03-26
K041243	Tyco Healthcare	DOVER RED RUBBER ROBINSON CATHETER	2004-07-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2013	C.R. Bard, Inc., Urological Division	2	8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Similar Registrations

Registration Number	Establishment Name	Location
3011987967	ConvaTec, Inc.	Greensboro, NC, US
8040607	BARD SDN. BHD.	KULIM Kedah, MY
3009504230	Sterigenics Radiation Technologies IN, Inc	Columbia City, IN, US
3007829657	ROBLING MEDICAL, LLC	Youngsville, NC, US
3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013530345. Last updated year: 2026. Please use registration number 3013530345 when referencing this establishment in official correspondence.