Manufacturer registered with FDA
Medesy Srl
Maniago, Italy. Lists 25 dental device types with FDA across 1 registered establishment.
- Device types listed
- 25
- Brands and models
- 25
- 510(k) clearances
- 0as applicant
- Markets registered in
- 12226 registrations outside the US
- Establishments
- 1Italy
Registered in 12 markets
Where regulators' registries name Medesy Srl 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 | Medesy Srl | 25 device types | — | Below |
| Serbia | ALIMS | Manufacturer | MEDESY SRL | 58 | 2021–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | MEDESY s.r.l.MEDESY S.R.L · MEDESY srl · +2 | 54 | 2001–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Medesy S.r.l.Medesy S.R.L. | 46 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDESY S.r.l.MEDESY S.R.L. · MEDESY SRL | 31 | 2017–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDESY SRL | 10 | 2011–2018 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | MEDESY srl | 9 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MEDESY S.R.L. | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | MEDESY SRL | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEDESY S.R.L.MEDESY SRL | 4 | 2006–2024 | Pure Global AI |
| European Union | EUDAMED | Registration holder | MEDESY srl | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Medesy Srl | 1 | 2018–2018 | 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 Medesy Srl currently lists, by FDA device type, with the brand and model names on the listing.
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 |
|---|---|---|
| MEDESY srlFDA reg. 9680244 | MANIAGO Pordenone, Italy | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007416). 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.