Manufacturer registered with FDA
Fomed Industries Inc.
Qian Jiang, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 737 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Fomed Industries Inc. 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 | Fomed Industries Inc. | 5 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | FOMED INDUSTRIES INC. | 21 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | FOMED INDUSTRIES INC. | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Fomed Industries Inc | 1 | 2017–2017 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | FOMED INDUSTRIES INC. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Fomed Industries Inc. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Fomed Industries Inc. | 1 | 2010–2010 | 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 Fomed Industries Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Maker | Cotton roll | 2012 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Tray,Impression,Preformed(Impression tray) | 2016 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Air / Water Syringe Tips | 2024 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Mixing Bowl | 2024 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Unit, Operative Dental, Accessories (Barrier Film), Half Chair Sleeves, Headrest covers Sleeves, Tray Sleeves | 2016 |
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 |
|---|---|---|
| Fomed Industries IncFDA reg. 9680887 | Qian Jiang Hubei, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9010881). 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.