Manufacturer registered with FDA
Intersurgical S.p.A.
Mirandola (MO) Italy, Italy. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 665 registrations outside the US
- Establishments
- 1Italy
Registered in 6 markets
Where regulators' registries name Intersurgical S.p.A. 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 | Intersurgical S.p.A. | 1 device types | — | Below |
| European Union | EUDAMED | Registration holder | Intersurgical SpAIntersurgical Ltd | 34 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | INTERSURGICAL S.P.A.INTERSURGICAL SPA | 25 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | INTERSURGICAL S.P.A. | 4 | 2023–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | INTERSURGICAL SPA | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | INTERSURGICAL S.p.a. | 1 | 2021–2021 | 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 Intersurgical S.p.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | CP903 | 2020 |
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 |
|---|---|---|
| INTERSURGICAL S.P.A.FDA reg. 3010741366 | Mirandola (MO) Italy Modena, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10077794). 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.