The following data is part of a premarket notification filed by U-needle B.v. with the FDA for Bella-mu.
| Device ID | K190962 |
| 510k Number | K190962 |
| Device Name: | Bella-mu |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | U-Needle B.V. De Veldmaat 10 Enschede, NL 7522 Nm |
| Contact | Gert Veldhuis |
| Correspondent | Robert Packard Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-12 |
| Decision Date | 2020-02-03 |