Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016447772

FEI Number

3016447772

Entity Name

UROSYSTEM ZRT

City/State/Country

Budapest, HU

Establishment Address

Szent Istvan park 26, Budapest 1137, HU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Urosystem Zrt (Owner Number: 10062314)

Owner / Operator Contact Address

Szent Istvan park 26, Fsz.2., Budapest, HU-BU 1137, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UroDapter / MID-ii

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2020-01-10

Official Correspondent

Jeno Kunovits

US Agent Details

John Beasley Business: MedTech Review, LLC Email: john@medtechreview.com Phone: (702) 7236889

Related Public Records

Same Entity

Urosystem Zrt

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016447772. Last updated year: 2026. Please use registration number 3016447772 when referencing this establishment in official correspondence.