FDA Registration Active 🇺🇸 United States

Coloplast Manufacturing US, LLC.

Reg #: 3030087693 · FEI: 3030087693 · Expires 2026
Products
9
Proprietary Names
143
Establishment Types
1
Classifications
9

Registration Details

Registration Name
Coloplast Manufacturing US, LLC.
Registration Number
3030087693
FEI Number
3030087693
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
4008 Heritage Drive
City
Brookshire
State
TX
ZIP
77423
Country
US

Regulatory Submissions

510(k) Number
K211911

Owner / Operator

Firm Name
Coloplast Corp.
Operator Number
8010144
Address
1601 West River Road North
City
Minneapolis
State
MN
Postal Code
55411
Country
US

Products

Device Name Product Code
Catheter, Nephrostomy LJE
Stent, Ureteral FAD
Garment, Protective, For Incontinence EYQ
Irrigator, Ostomy EXD
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
Catheter, Nephrostomy, General & Plastic Surgery GBO
Dressing, Wound, Occlusive NAD
Collector, Ostomy EXB
Bandage, Liquid, Skin Protectant NEC

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 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 Comfeel Cleanser SeaClens Coloplast Prep Derma-Gard Brava Barrier Cream Brava Skin Barrier Wipe Brava Skin Barrier Spray Comfeel Barrier Cream Prep Barrier Film

Establishment Types

Repack or Relabel Medical Device