FDA Registration
Active
🇭🇺 Hungary
COLOPLAST HUNGARY KFT
Reg #: 3003814961
·
FEI: 3003814961
·
Expires 2026
Products
13
Proprietary Names
132
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- COLOPLAST HUNGARY KFT
- Registration Number
- 3003814961
- FEI Number
- 3003814961
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BUZAVIRAG UT 15
- City
- TATABANYA Komarom-Esztergom
- Country
- HU
Regulatory Submissions
- 510(k) Number
- K090217
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
- [email protected]
- Phone
- 612 7302063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2009-05-13 |
| Catheter, Ureteral, Gastro-Urology | EYB | Class 2 | Gastroenterology, Urology | No | 2019-02-19 |
| Dilator, Catheter, Ureteral | EZN | Class 2 | Gastroenterology, Urology | No | 2017-11-29 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 1995-11-02 |
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 1995-11-02 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2009-01-15 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2004-03-24 |
| Catheter, Continuous Irrigation | GBQ | Class 1 | General, Plastic Surgery | No | 2006-05-17 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2021-08-19 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2022-11-22 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2005-09-08 |
| Irrigator, Ostomy | EXD | Class 2 | Gastroenterology, Urology | No | 2012-08-01 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2001-12-04 |
Proprietary Names
BoNee Needle
KT RUP
Ureteral Dilators and Percutaneous Nephrostomy Dilators
Floppy Tip Hydro-Coated Ureteric Catheters
Flush Ureteric Catheters
Ureteric Catheters
Conveen Security+
Conveen Contour
Coloplast Fistula Bed Drainage Bag
Coloplast Flexible Lid
COLOPLAST FISTULA AND WOUND MANAGAMENT SYSTEM
Folysil
Silicone Prostatectomy Catheter
Conveen Active
Conveen Leg Bag Strap
Conveen Standard
Conveen Urine Bag Hanger
Coloplast Urostomy night bag
COLOPLAST DRAIN PORT
Vortek Single Loop Ureteral Stent
Kolibri Percutaneous Nephrostomy Catheters
Kolibri Percutaneous Nephrostomy Kits
Kolibri Direct Puncture Sets
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
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
Elefant Suction-Irrigation Device
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device