FDA Registration
Active
🇧🇪 Belgium
Bard European Distribution Center NV
Reg #: 3002504068
·
FEI: 3002504068
·
Expires 2026
Products
7
Proprietary Names
41
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Bard European Distribution Center NV
- Registration Number
- 3002504068
- FEI Number
- 3002504068
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hagelberg 2
- City
- Olen Antwerpen
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K063532
- PMA Number
- P130029
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2008-08-22 |
| System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | PFV | Class 3 | Unknown | No | 2014-08-04 |
| Stent, Superficial Femoral Artery | NIP | Class 3 | Unknown | No | 2009-06-12 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2007-02-27 |
| Stent, Iliac Vein | QAN | Class 3 | Unknown | No | 2019-03-13 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 1999-12-16 |
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2009-02-20 |
Proprietary Names
LifeStar Biliary Stent System
E-LUMINEXX Biliary Stent System
Fluency Plus Endovascular Stent Graft
LifeStent 5F Vascular Stent System
Lifestent Solo Vascular Stent System
Lifestent and Lifestent XL Vascular Stent System
LifeStent XL Biliary Stent System
LifeStent Biliary Stent System
Covera Vascular Covered Stent
Loc-Strap
Bard Male External Catheter (OTC)
Bard Infection Control Urinary
Needleless Sample Port Control Fit
Urine Collection Container -
bag/urinary drainage unit
Bard Deluxe Dispoz-A-Bag Drainage
Bag (Leg Bag)
Urinary Drainage Unit(urinary leg
Urotrack Plus (Model 220)
Bard Leg Bag Holder
w/ accessories)
Bed Bag
SureStep Foley Tray System Add-A-Foley Catheter (for Canada)
Bard Foley Catheterization Tray Uro-Prep Tray (for Canada)
SureStep Foley Tray System Complete Care Add-A-Foley Catheter (for Canada)
Bard Standard Latex Free Foley Tray without Catheter (for Canada)
Bard Male External Latex Disposable Catheter
Bardia Foley Catheter Insertion
w/o Catheter with Lubricant in
SureStep Intermittent Catheter Tray
Bard® Universal Catheterization Tray
Bardia Urethral Catheter Tray
5cc Balloon w/o Catheter
w/o Catheter
Foley Catheter Insertion Tray for
30cc Balloon w/o Catheter
Bard Foley Catheterization Tray
Venovo Venous Stent System
Lifestent XL Biliary Stent System
E-Luminexx Vascular Stent System
LifeStar Vascular Stent System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device