COLOPLAST (CHINA) LTD.

FDA Device Registration & Listing · ZHUHAI Guangdong, CN · Registration 3005945907

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005945907
FEI Number
3005945907
Entity Name
COLOPLAST (CHINA) LTD.
City/State/Country
ZHUHAI Guangdong, CN
Establishment Address
No. 202, Bao Cheng Road, ZHUHAI FREE TRADE ZONE, ZHUHAI Guangdong 519030, CN
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Coloplast Paste SenSura Ostomy bag SenSura Mio Kids ostomy bag Brava Elastic Tape Belt SenSura Mio Original Brava Strip Paste Sensura Flex ostomy bag Brava Paste Brava Powder Coloplast Filtrodor SenSura Mio Kids urostomy bag Sensura Magnum Brava Lubricating Deodorant SenSura Post Op ostomy bag SenSura Xpro ostomy bag Brava Protective Seal Brava Mouldable Rings SenSura Urostomy bag SenSura Mio Baby ostomy baseplate SenSura Click Xpro ostomy baseplate SenSura Mio Flex ostomy bag Brava Elastic Tape SenSura Mio Post Op ostomy bag Assura Urostomy bag SenSura Mio Convex High Output ostomy bag SenSura Mio Soft convex ostomy bag Coloplast Rings SenSura Mio Click Ostomy bag Brava Elastic Tape Straight SenSura Click ostomy bag SenSura Mio Kids Flex urostomy bag SenSura Mio ostomy bag SenSura Mio Concave Ostomy bag Sensura Flex Xpro ostomy baseplate Sensura Mio Flex Brava Protective Seal Convex SenSura Magnum SenSura Mio Soft convex urostomy bag SenSura Mio Light convex ostomy baseplate Sensura Flex Ostomy baseplate SenSura Mio Flex ostomy baseplate SenSura Mio High Output ostomy bag SenSura Mio Kids Flex ostomy bag SenSura Mio Click High Output ostomy bag SenSura Drainable bag with soft tap SenSura Mio Flex High Output ostomy bag SenSura Mio Concave Ostomy baseplate Mio Flex Kit no filter SenSura Mio Light convex urostomy bag SenSura Mio Concave Urostomy bag SenSura Xpro 1pc Uro Kit SenSura Mio 2-piece Click Assura 1pc Kit SenSura Xpro 1pc CV Uro Kit SenSura Mio Flex Uro Kit Brava belt SenSura Click CV Kit Elastic Barrier Strips PrePack SenSura Mio 1-piece urostomy SenSura Mio Urostomy bag Brava Belt for SenSura Mio SenSura Mio baby ostomy bag SenSura Click Ostomy baseplate SenSura Mio Convex Flip 1-piece SenSura Mio Click ostomy baseplate Brava Skin Cleanser SenSura Mio Flex Kit Assura CV Kit Flex Xpro CV Kit Sensura Flex urostomy bag Assura Kit SenSura Mio Convex Flip urostomy pouch SenSura Mio 2-piece Flex SenSura Mio Convex Flip 1-piece drainable Assura Night bag Assura Urostomy Pouch SenSura Mio Flex 2-piece Urostomy SenSura Mio Click Kit Coloplast Care Kit Coloplast Clamp Assura Ostomy Pouch Sensura Mio Uro Bag Adaptor SenSura Mio Convex light 1-piece urostomy SenSura Mio 1pc Kit SenSura Click urostomy bag SenSura Mio Flex urostomy bag SenSura Xpro Urostomy SenSura Mio 1-piece SenSura Click Kit SenSura Flex Xpro Kit SenSura Flex Kit SenSura Xpro Urostomy bag SenSura Mio Light convex ostomy bag Coloplast Discharge Kit SenSura Mio Soft convex ostomy baseplate SenSura Mio Deep convex ostomy baseplate SenSura Mio Kids ostomy baseplate SenSura Mio Deep convex urostomy bag SenSura Mio Deep convex ostomy bag SenSura Mio Click urostomy bag SenSura Mio Convex Light 1-piece Self-Cath Self-Cath Plus Conveen Active Conveen Leg Bag Strap Conveen Standard Conveen Urine Bag Hanger Coloplast Urostomy night bag Conveen Security+ Conveen Contour FREEDOM Penilex CONVEEN OPTIMA Self-Cath Extension Tube CONVEEN SECURITY +

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2005-09-08
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2023-01-10
NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2004-03-24
NNX Device, Incontinence, Urosheath Type, Non-Sterile Gastroenterology, Urology Class 1 876.5250 2007-07-18

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
3032906574 Coloplast Manufacturing US LLC Burnsville, MN, US
3030087693 Coloplast Manufacturing US, LLC. Brookshire, TX, US
3008262278 Coloplast Hungary, KFT Tatabanya, HU
9610711 COLOPLAST MANUFACTURING FRANCE, SAS Sarlat la Caneda Cedex Dordogne, FR

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2012 Convatec Inc. 1
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005945907. Last updated year: 2026. Please use registration number 3005945907 when referencing this establishment in official correspondence.
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