Data / Medical devices / Netherlands / U-Needle B.V.
U-Needle B.V.: FDA-registered device maker in Enschede Overijssel, Netherlands, 1 510(k) clearance
U-Needle B.V. is registered with the FDA (registration 3009853488) in Enschede Overijssel, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 3, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009853488
- Address
- De Veldmaat 10, Enschede Overijssel, Netherlands, 7522 NM
- Owner or operator
- U-Needle BV (10080399)
- Roles
- Manufacturer
- First device listed
- January 29, 2021
- Registered through
- 2026
- Brand names listed
- Bella-mu
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 3, 2020 | K190962 | Bella-mu | FMI | Substantially Equivalent | U-Needle B.V. | accessdata.fda.gov |
Compare with other makers
Updated February 3, 2020. 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.