Data / Medical devices / Belgium / Bard European Distribution Center NV
Bard European Distribution Center NV: FDA-registered device maker in Olen Antwerpen, Belgium, 4 510(k) clearances and 6 PMA approvals
Bard European Distribution Center NV is registered with the FDA (registration 3002504068) in Olen Antwerpen, Belgium. It lists 8 device types. The FDA files 4 510(k) clearances and 6 PMA approvals under its listings, the newest dated September 25, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3002504068
- Address
- Hagelberg 2, Olen Antwerpen, Belgium, 2250
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Exporter to the US
- First device listed
- December 16, 1999
- Registered through
- 2027
- Brand names listed
- 30cc Balloon w/o Catheter, 5cc Balloon w/o Catheter, Bag (Leg Bag), Bard Deluxe Dispoz-A-Bag Drainage, Bard Foley Catheterization Tray, Bard Foley Catheterization Tray Uro-Prep Tray (for Canada), Bard Infection Control Urinary, Bard Leg Bag Holder and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Exporter to the US | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Exporter to the US | accessdata.fda.gov |
| Shunt, Portosystemic, Endoprosthesis | MIR | 3 | Exporter to the US | accessdata.fda.gov |
| Stent, Iliac | NIO | 3 | Exporter to the US | accessdata.fda.gov |
| Stent, Iliac Vein | QAN | 3 | Exporter to the US | accessdata.fda.gov |
| Stent, Superficial Femoral Artery | NIP | 3 | Exporter to the US | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Exporter to the US | accessdata.fda.gov |
| System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment | PFV | 3 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 30, 2013 | K130792 | LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM | FGE | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| May 30, 2008 | K063532 | BARD E LUMINEXX BILIARY STENT | FGE | Unknown | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| March 23, 2006 | K060487 | LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM | FGE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 21, 2005 | K053404 | LIFESTENT FLEXSTART BILIARY STENT SYSTEM | FGE | Unknown | Edwards Lifesciences, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 25, 2026 | P250050 | Liverty TIPS Stent Graft | MIR | 1 | October 23, 2026 | accessdata.fda.gov |
| March 13, 2019 | P180037 | Venovo Venous Stent System | QAN | 14 | June 10, 2026 | accessdata.fda.gov |
| July 30, 2018 | P170042 | Covera Vascular Covered Stent | PFV | 14 | June 10, 2026 | accessdata.fda.gov |
| June 17, 2014 | P130029 | FLUENCY PLUS ENDOVASCULAR STENT GRAFT | PFV | 14 | June 22, 2026 | accessdata.fda.gov |
| February 13, 2009 | P070014 | LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM | NIP | 66 | June 10, 2026 | accessdata.fda.gov |
| December 4, 2008 | P080007 | BARD E-LUMINEXX VASCULAR STENT | NIO | 24 | May 26, 2022 | accessdata.fda.gov |
Compare with other makers
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
- All makers of Stent, Iliac
- All makers of System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Collector, Urine, (And Accessories) For Indwelling Catheter
- All makers of Shunt, Portosystemic, Endoprosthesis
Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.