Manufacturer registered with FDA
Omnia SRL
Northbrook, IL, United States. Lists 9 dental device types with FDA across 2 registered establishments.
- Device types listed
- 9
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 9135 registrations outside the US
- Establishments
- 2Italy
Registered in 9 markets
Where regulators' registries name Omnia 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 | Omnia SRL | 9 device types | — | Below |
| European Union | EUDAMED | Registration holder | Omnia S.r.l | 52 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Omnia S.R.LOmnia SPA | 19 | 2009–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | OMNIA SRL | 17 | 2013–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Omnia S.r.l | 14 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Omnia S.R.LOMNIA SRL · OMNIA Spa · +2 | 11 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Omnia SrlOMNIA S.r.l · OMNIA S.R.L. · +2 | 9 | 2005–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Omnia SrlOMNIA · OMNIA S.P.A. · +1 | 7 | 2009–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | OMNIA srlOmnia S.p.A | 6 | — | 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 Omnia SRL currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | IRRIGATION LINE | 2003 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | SplitAir | 2003 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | MAXIL | 2012 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | ASPIRATION SYSTEM | 2003 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | LIGHT BARRIEROMNITEX COMNITEX URAY BARRIERSENSOTEX | 2011 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | maxil tray for instruments | 2015 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | TISSUE PUNCH | 2008 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Omnia Surgical line | 2015 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Omnitex sheath | 2015 |
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 |
|---|---|---|
| OMNIA SRLFDA reg. 3004361903 | FIDENZA Parma, Italy | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
| OMNIA SRLFDA reg. 3011710821 | Mirandola Modena, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9059817). 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.