COLOPLAST A/S

FDA Device Registration & Listing · HUMLEBAEK Hovedstaden, DK · Registration 9610694

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
9610694
FEI Number
3002806731
Entity Name
COLOPLAST A/S
City/State/Country
HUMLEBAEK Hovedstaden, DK
Establishment Address
HOLTEDAM 1, HUMLEBAEK Hovedstaden DK-3050, DK
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
PMA Number
N/A

All Registered Proprietary Names

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 WounDres Biatain Fiber Ag Sure Cath Set SpeediCath Flex Coude Pro SpeediCath Compact Male SpeediCath Compact Male Kit SpeediCath Compact Set Female Self-Cath Self-Cath Plus Biatain Ag Adhesive Biatain Ag Non-Adhesive Coloplast Fistula Bed Drainage Bag Coloplast Flexible Lid COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM Biatain Silicone AG Luja Female COLOPLAST DRAIN PORT SpeediCath Compact Set male Peristeen Plus SpeediCath Flex Set SpeediCath Flex Set with Accessories Brava Baby Adhesive Remover 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 Coloplast Ostomy Rod SpeediCath Soft Comfeel Cleanser SeaClens Coloplast Prep Derma-Gard Brava Lubricating Deodorant Brava Barrier Cream Brava Skin Barrier Wipe Brava Skin Barrier Spray Comfeel Barrier Cream Prep Barrier Film 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 Luja Coude SpeediCath Standard SpeediCath Standard with Accessories

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2000-12-20
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic Unknown Class U N/A 2008-03-04
FRO Dressing, Wound, Drug Unknown Class U N/A 2024-04-29
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2025-01-10
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2019-07-11
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2022-05-20
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2024-01-29
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2023-01-10
FRO Dressing, Wound, Drug Unknown Class U N/A 2010-03-02
FON Bag, Drainage, With Adhesive, Ostomy Gastroenterology, Urology Class 1 876.5900 1995-11-02
FRO Dressing, Wound, Drug Unknown Class U N/A 2020-03-19
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-07-29
GBQ Catheter, Continuous Irrigation General, Plastic Surgery Class 1 878.4200 2006-05-17
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2023-08-03
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
PQE Ostomy Care Kit Gastroenterology, Urology Class 1 876.5900 2018-09-17
EXD Irrigator, Ostomy Gastroenterology, Urology Class 2 876.5895 2012-08-01
EZP Rod, Colostomy Gastroenterology, Urology Class 2 876.4270 2024-01-23
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2020-08-05
NEC Bandage, Liquid, Skin Protectant General Hospital Class 1 880.5090 2008-03-05
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2005-09-08
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2025-07-07
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2019-01-21

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
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31
K954741 Derma Sciences, Inc. DERMAGRAN WENT DRESSING (DEXTROSE-SALINE) 1995-11-01
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019 COVIDIEN LLC 1
Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 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 9610694. Last updated year: 2026. Please use registration number 9610694 when referencing this establishment in official correspondence.
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