Data / Medical devices / Italy / Medency SRL
Medency SRL: FDA-registered device maker in Vicenza Veneto, Italy, 2 510(k) clearances
Medency SRL is registered with the FDA (registration 3030090167) in Vicenza Veneto, Italy. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030090167
- Address
- Via degli Ontani, 48 - Vicenza (Italy), Vicenza Veneto, Italy, 36100
- Owner or operator
- Medency Srl (10089308)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 28, 2023
- Registered through
- 2026
- Brand names listed
- Fibercure, Primo Dental Laser, Rapido Medical Laser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser Activator For Polymerization | QNF | 2 | Contract manufacturer | accessdata.fda.gov |
| Laser, Dental, Soft Tissue | NVK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 24, 2024 | K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) | GEX | Substantially Equivalent | Medency S.R.L. | accessdata.fda.gov |
| November 27, 2023 | K232222 | Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) | NVK | Substantially Equivalent | Medency S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Laser Activator For Polymerization
- All makers of Laser, Dental, Soft Tissue
Updated October 24, 2024. 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.