Data / Medical devices / Italy / Unibell SRL
Unibell SRL: FDA-registered device maker in Calco Lecco, Italy, 1 510(k) clearance
Unibell SRL is registered with the FDA (registration 3007491751) in Calco Lecco, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007491751
- Address
- Via Indipendenza, 27, Calco Lecco, Italy, 23885
- Owner or operator
- UNIBELL SRL (10060358)
- Roles
- Manufacturer
- First device listed
- April 30, 2019
- Registered through
- 2026
- Brand names listed
- Human Tecar HCR 1002 and accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 10, 2018 | K181211 | Human Tecar HCR 1002 | PBX | Substantially Equivalent | Unibell S.R.L | accessdata.fda.gov |
Compare with other makers
Updated September 10, 2018. 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.