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Med Pro Medical B.V: FDA-registered device maker in Veenendaal Utrecht, Netherlands, 2 510(k) clearances

Name: Med Pro Medical B.V FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Med Pro Medical B.V is registered with the FDA (registration 3013530345) in Veenendaal Utrecht, Netherlands. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 19, 2021. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3013530345
Address: Vendelier 45 E, Veenendaal Utrecht, Netherlands, 3905PC
Owner or operator: MED pro Medical B.V (10053600)
Roles: Contract manufacturer, Exporter to the US, Specification developer
First device listed: December 21, 2016
Registered through: 2027
Brand names listed: Meatal Dilator, Stone Basket, UroGen Ureteral Catheter

Devices it lists

Device	Product code	Class	Role	Source
Bougie, Urological	FAX	1	Specification developer	accessdata.fda.gov
Catheter, Coude	EZC	2	Exporter to the US, Specification developer	accessdata.fda.gov
Catheter, Urological	KOD	2	Contract manufacturer, Exporter to the US, Specification developer	accessdata.fda.gov
Dilator, Catheter	GCC	1	Specification developer	accessdata.fda.gov
Dilator, Urethral	KOE	2	Specification developer	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Specification developer	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
November 19, 2021	K211032	Urinary Catheter 12 Fr, Urinary Catheter 16 Fr	KOD	Substantially Equivalent	Urogen Pharma, Ltd.	accessdata.fda.gov
October 30, 2018	K180354	UroGen Ureteral Catheter	KOD	Substantially Equivalent	Urogen Pharma, Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 19, 2021. 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.