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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2022-11-22 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2022-11-22 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2009-01-15 |
| Irrigator, Ostomy | EXD | Class 2 | Gastroenterology, Urology | No | 2012-08-01 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2023-08-22 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 1995-02-27 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2000-12-20 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2005-09-08 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2008-03-05 |
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