Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030087693

FEI Number

3030087693

Entity Name

Coloplast Manufacturing US, LLC.

City/State/Country

Brookshire, TX, US

Establishment Address

4008 Heritage Drive, Brookshire, TX 77423, US

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Kolibri Percutaneous Nephrostomy Catheters Kolibri Percutaneous Nephrostomy Kits Kolibri Direct Puncture Sets Manhood Pouch Coloplast Irrigation Colotip Assura Irrigation Pressplate SenSura Mio Hospital Irrigation Set Assura Irrigation Set SenSura Mio Irrigation Sleeve Coloplast Irrigation Set Kit Sensura Mio Irrigation Sleeves Self-Cath Closed System Chiba needle 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2022-11-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2022-11-22
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2009-01-15
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2012-08-01
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2023-08-22
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	1995-02-27
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2000-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3008262278	Coloplast Hungary, KFT	Tatabanya, HU
9610711	COLOPLAST MANUFACTURING FRANCE, SAS	Sarlat la Caneda Cedex Dordogne, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6001
Z-0038-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Z-0039-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
Z-0040-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
Z-0041-2023	Hobbs Medical, Inc.	2	Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027

Similar Registrations

Registration Number	Establishment Name	Location
3019946783	RETROPERC, INC.	Jersey City, NJ, US
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB
3030446844	PLATINUM FOCUS GROUP LTD.	London London, City of, GB
9610711	COLOPLAST MANUFACTURING FRANCE, SAS	Sarlat la Caneda Cedex Dordogne, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030087693. Last updated year: 2026. Please use registration number 3030087693 when referencing this establishment in official correspondence.