Data / Medical devices / Italy / Sportarredo Group S.C.
Sportarredo Group S.C.: FDA-registered device maker in GRUARO Venezia, Italy, 3 510(k) clearances
Sportarredo Group S.C. is registered with the FDA (registration 8021093) in GRUARO Venezia, Italy. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 6, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8021093
- FEI number
- 3001048992
- Address
- Via Dell Industria 7, GRUARO Venezia, Italy, 30020
- Owner or operator
- SPORTARREDO GROUP S.C. (8021093)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- February 25, 2020
- Registered through
- 2026
- Brand names listed
- KALFASUN, SPORTARREDO, Sportarredo B-Phase, Sportarredo HPO, Sportarredo LP1, Sportarredo LP2, Sportarredo LP3, Sportarredo MasterSun 360 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Booth, Sun Tan | LEJ | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 6, 2017 | K161394 | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | LEJ | Substantially Equivalent | Sportarredo Group S.C. | accessdata.fda.gov |
| February 25, 2016 | K152141 | High Pressure Tanning Lamps | LEJ | Substantially Equivalent | Blv Licht-Und Vakuumtechnik GmbH | accessdata.fda.gov |
| January 27, 2016 | K152233 | BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux | LEJ | Substantially Equivalent | Sportarredo Group S.C. | accessdata.fda.gov |
Compare with other makers
Updated July 6, 2017. 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.