Data / Medical devices / Belgium / Wase Werkplaats VZW
Wase Werkplaats VZW: FDA-registered device maker in Temse Oost-Vlaanderen, Belgium, 1 510(k) clearance
Wase Werkplaats VZW is registered with the FDA (registration 3006762440) in Temse Oost-Vlaanderen, Belgium. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006762440
- Address
- Kapelanielaan 20, Temse Oost-Vlaanderen, Belgium, 9140
- Owner or operator
- Wase Werkplaats Vzw (10095936)
- Roles
- Repackager or relabeler
- First device listed
- May 26, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 19, 2021 | K212015 | BD Nano 2nd Gen Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Compare with other makers
Updated November 19, 2021. 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.