Data / Medical devices / Italy / Triworks Group S.R.L.
Triworks Group S.R.L.: FDA-registered device maker in Palata Campobasso, Italy, 2 510(k) clearances
Triworks Group S.R.L. is registered with the FDA (registration 3020623326) in Palata Campobasso, Italy. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020623326
- Address
- San Rocco, 58B, Palata Campobasso, Italy, 86037
- Owner or operator
- Triworks Group S.r.l. (10079735)
- Roles
- Manufacturer
- First device listed
- July 18, 2022
- Registered through
- 2026
- Brand names listed
- AgeJet, Eterna, Medical RF, PurePlasma
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 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 |
|---|---|---|---|---|---|---|
| July 7, 2022 | K212472 | AgeJet | GEI | Substantially Equivalent | Triworks Group Srl | accessdata.fda.gov |
| November 6, 2020 | K192621 | Medical RF | GEI | Substantially Equivalent | Triworks Group Srl | accessdata.fda.gov |
Compare with other makers
Updated July 7, 2022. 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.