Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003814961

FEI Number

3003814961

Entity Name

COLOPLAST HUNGARY KFT

City/State/Country

TATABANYA Komarom-Esztergom, HU

Establishment Address

BUZAVIRAG UT 15, TATABANYA Komarom-Esztergom 2800, HU

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Coloplast Corp. (Owner Number: 8010144)

Owner / Operator Contact Address

1601 West River Road North, Minneapolis, MN 55411, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201436

PMA Number

N/A

All Registered Proprietary Names

BoNee Needle KT RUP Ureteral Dilators and Percutaneous Nephrostomy Dilators Floppy Tip Hydro-Coated Ureteric Catheters Flush Ureteric Catheters Ureteric Catheters Conveen Security+ Conveen Contour Coloplast Fistula Bed Drainage Bag Coloplast Flexible Lid COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM Folysil Silicone Prostatectomy Catheter Conveen Active Conveen Leg Bag Strap Conveen Standard Conveen Urine Bag Hanger Coloplast Urostomy night bag Conveen Security+ Conveen Contour COLOPLAST DRAIN PORT Vortek Single Loop Ureteral Stent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2009-05-13
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2019-02-19
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2017-11-29
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2019-02-19
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Gastroenterology, Urology	Class 1	876.5250	1995-11-02
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1995-11-02
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2009-01-15
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2008-01-08
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2004-03-24
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2006-05-17
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2021-08-19

Official Correspondent

No official correspondent registered.

US Agent Details

Jason Woehrle Business: COLOPLAST CORP. Email: usjawo@coloplast.com Phone: (612) 7302063

Related Public Records

Same Entity

Coloplast Corp.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011307048	Coloplast A/S - Mordrup Site	Espergaerde Hovedstaden, DK
3005945907	COLOPLAST (CHINA) LTD.	ZHUHAI Guangdong, CN
3032906574	Coloplast Manufacturing US LLC	Burnsville, MN, US
3030087693	Coloplast Manufacturing US, LLC.	Brookshire, TX, US
3008262278	Coloplast Hungary, KFT	Tatabanya, HU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003814961. Last updated year: 2026. Please use registration number 3003814961 when referencing this establishment in official correspondence.