Data / Medical devices / Italy / B&M S.R.L.
B&M S.R.L.: FDA-registered device maker in Milano, Italy, 1 510(k) clearance
B&M S.R.L. is registered with the FDA (registration 3013539104) in Milano, Italy. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013539104
- Address
- Via Leonardo Bruni 25, Milano, Italy, 20158
- Owner or operator
- B&M S.r.l. (10088836)
- Roles
- Manufacturer
- First device listed
- October 16, 2023
- Registered through
- 2026
- Brand names listed
- T-FACE, T-SHAPE 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Light Induced Heating | NUV | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 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 |
|---|---|---|---|---|---|---|
| September 22, 2023 | K231092 | T-SHAPE 2 | NUV | Substantially Equivalent | B&M S.R.L. Marketing Nel Benessere | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Vacuum, Light Induced Heating
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Brush, Dermabrasion, Powered
Updated September 22, 2023. 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.