Data / Medical devices / Belgium / BD European Distribution Center
BD European Distribution Center: FDA-registered device maker in Temse Oost-Vlaanderen, Belgium, 4 510(k) clearances
BD European Distribution Center is registered with the FDA (registration 3013055489) in Temse Oost-Vlaanderen, Belgium. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013055489
- Address
- Laagstraat 57, Temse Oost-Vlaanderen, Belgium, B-9140
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Exporter to the US
- First device listed
- August 3, 2001
- Registered through
- 2026
- Brand names listed
- Alaris Pump Sets, BD PhaSeal Optima Connecting Set (C83-O), BD PhaSeal Optima Spike Set (C180-O), BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder, Needle, Aspiration and Injection, Reusable, PAXgene Blood RNA System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Exporter to the US | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Exporter to the US | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Exporter to the US | accessdata.fda.gov |
| System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test | NTW | 2 | Exporter to the US | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | 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 |
|---|---|---|---|---|---|---|
| September 12, 2025 | K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| April 18, 2005 | DEN050003 | PAXGENE BLOOD RNA SYSTEM | NTW | Unknown | Preanalytix GmbH | accessdata.fda.gov |
| August 25, 1981 | K811885 | 30-30-2 700 SYRINGE EXTENSION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Needle, Aspiration And Injection, Reusable
Updated September 12, 2025. 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.