Manufacturer registered with FDA
Euronda SPA
VICENZA, Italy. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 14192 registrations outside the US
- Establishments
- 1Italy
Registered in 14 markets
Where regulators' registries name Euronda SPA as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Euronda SPA | 5 device types | — | Below |
| European Union | EUDAMED | Registration holder | EURONDA S.P.A. | 83 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | EURONDA S.P.A. | 24 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | EURONDA S.P.A.EURONDA S.P.A | 16 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | EURONDA S.P.AEURONDA SPA · EURONDA S.P.A. | 13 | 2010–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Euronda SPA | 12 | 2015–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | EURONDA SPA | 10 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | EURONDA - SPAEURONDA SPA | 8 | 2011–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | EURONDA S.P.AEURONDA S.p.A · EURONDA S.p.A. · +2 | 8 | 2004–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Euronda SpaEURONDA SPA · Euronda · +1 | 5 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | EURONDA S.p.A. | 5 | 2024–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | EURONDA SPA | 4 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | EURONDA SPA | 3 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | EURONDA S.p.A. | 1 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Euronda SPA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | MONOART EM15 SALIVA EJECTOR | 2010 |
| Roll CottonEFN · Class 1 | — | Lister | MONOART COTTON ROLLS | 2015 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Irrigation Set For MachineryManual Irrigation SetTubing Extension For Mechanical Irrigation Set | 2025 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | KIT MONOART® 4P 15,0 FIXEDKIT MONOART® 5P 15,0 FIXEDKIT MONOART® 8P 15,0 FIXEDMONOART APRON PG20MONOART APRON PG30MONOART TOWELMONOART TOWEL UP | 2015 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Kit Monoart Dentist Chair Cover | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EURONDA SPAFDA reg. 3008494033 | Sandrigo Vicenza, Italy | Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033261). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.