Manufacturer registered with FDA
Ghimas SPA
Casalecchio di Reno, Italy. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1040 registrations outside the US
- Establishments
- 1Italy
Registered in 10 markets
Where regulators' registries name Ghimas 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 | Ghimas SPA | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Ghimas S.p.A. | 14 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | GHIMAS S.P.A.GHIMAS SPA | 10 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | GHIMAS S.p.A | 6 | 2025–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | GHIMASGhimas S.p.A · Ghimas SpA | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Ghimas S.p.A | 3 | — | Pure Global AI |
| China | NMPA | Registration holder | 集美生股份有限公司GHIMAS S.p.A. | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | GHIMAS S.p.A. | 1 | 2018–2018 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GHIMAS S.p.A. | 1 | 2024–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Ghimas S.P.A | 1 | — | 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 Ghimas 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 |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | — | 2010 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | — | 2022 |
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 |
|---|---|---|
| GHIMAS SPAFDA reg. 3006644229 | Casalecchio di Reno Bologna, Italy | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034681). 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.