# U-Needle B.V.

- Location (FDA's records): Enschede, NL
- FDA decisions: 1 (2020–2020): 1 510(k) clearance
- Product codes: FMI (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K190962: Bella-mu (Feb 3, 2020)

Source page: https://510kreport.com/company/u-needle