Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006606901

FEI Number

3006606901

Entity Name

COLOPLAST HUNGARY KFT

City/State/Country

NYIRBATOR Szabolcs-Szatmar-Bereg, HU

Establishment Address

COLOPLAST UTCA 2, NYIRBATOR Szabolcs-Szatmar-Bereg 4300, HU

Establishment Type(s)

Manufacture 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

K200820

PMA Number

N/A

All Registered Proprietary Names

SpeediCath Soft Biatain Silicone AG Luja Set FREEDOM Penilex CONVEEN OPTIMA Self-Cath Extension Tube CONVEEN SECURITY + SpeediCath Compact Plus SpeediCath Compact Luja Coude Sure Cath Set Peristeen Plus SpeediCath Flex Set SpeediCath Flex Set with Accessories SpeediCath Compact Set Female Self-Cath Self-Cath Plus SpeediCath Compact Male SpeediCath Compact Male Kit BAND-AID Hydroseal Acne Blemish Patch Neutrogena Acne Blemish Patch Biatain Ag Adhesive Biatain Ag Non-Adhesive Coloplast Ostomy Rod Neutrogena Sensitive Skin Triangle Acne Patches Comfeel Plus Contour Biatain Soft-Hold Biatain Silicone Biatain Silicone Lite Biatain Silicone Non-Border Brava Protective Sheets Band-Aid Neutrogena Sensitive Skin Blemish Patches Biatain Silicone Fit Neutrogena Stubborn Acne Ultra-Thin Blemish Patches Mederma Compeed Comfeel Plus Biatain Adhesive Neutrogena Sensitive Skin Mini Acne Patches Comfeel Plus Transparent Biatain Super Biatain Non-Adhesive Neutrogena Sensitive Skin Nose Patches SpeediCath Compact Set male

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2020-08-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-03-19
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2025-05-08
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2007-07-18
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-01-04
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2025-07-07
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2025-01-10
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2023-06-28
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2023-06-28
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2022-09-29
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2024-01-29
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2023-01-10
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2022-05-20
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2006-11-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2010-03-02
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2024-01-23
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2000-12-20
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2023-08-03

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006606901. Last updated year: 2026. Please use registration number 3006606901 when referencing this establishment in official correspondence.