FDA Registration Active 🇭🇺 Hungary

Coloplast Hungary, KFT

Reg #: 3008262278 · FEI: 3008262278 · Expires 2026
Products
13
Proprietary Names
153
Establishment Types
1
Classifications
13

Registration Details

Registration Name
Coloplast Hungary, KFT
Registration Number
3008262278
FEI Number
3008262278
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Kerek utca 3
City
Tatabanya
Country
HU

Regulatory Submissions

510(k) Number
K203637

Owner / Operator

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

US Agent

Business Name
COLOPLAST CORP.
Contact Name
Jason Woehrle
Address
1601 West River Road N
City
Minneapolis
State
MN
ZIP
55411
Country
US
Phone
612 7302063

Products

Device Name Product Code
Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
Ostomy Care Kit PQE
Device, Incontinence, Urosheath Type, Non-Sterile NNX
Bag, Urine Collection, Leg, For External Use, Non-Sterile NNW
Rod, Colostomy EZP
Dressing, Wound, Occlusive NAD
Scissors, Medical, Disposable JOK
Catheter, Straight EZD
Solvent, Adhesive Tape KOX
Collector, Ostomy EXB
Bag, Urine Collection, Leg, For External Use, Sterile FAQ
Bandage, Liquid, Skin Protectant NEC
Bag, Drainage, With Adhesive, Ostomy FON

Proprietary Names

Purilon Brava Baby Adhesive Remover FREEDOM Penilex CONVEEN OPTIMA Self-Cath Extension Tube CONVEEN SECURITY + Conveen Active Conveen Leg Bag Strap Conveen Standard Conveen Urine Bag Hanger Coloplast Urostomy night bag Conveen Security+ Conveen Contour Coloplast Ostomy Rod 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 Ostomy Scissors SpeediCath Compact Plus SpeediCath Compact Brava Adhesive Remover Wipe Brava Adhesive Remover Spray 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 Coloplast Fistula Bed Drainage Bag Coloplast Flexible Lid COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM

Establishment Types

Repack or Relabel Medical Device