Manufacturer registered with FDA
Shanghai No. 2 Medical College Duhang Medical Equipment Fact
Shanghai, China. 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
- 314 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shanghai No. 2 Medical College Duhang Medical Equipment Fact 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 | Shanghai No. 2 Medical College Duhang Medical Equipment Fact | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shanghai No.2 Medical College Duhang Medical Equipment Factory | 13 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHANGHAI NO.2 MEDICAL COLLEGE DUHANG MEDICAL EQUIPMENT FACTORY | 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 Shanghai No. 2 Medical College Duhang Medical Equipment Fact currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Sputum suction unit, Manual suction unit, Electric suction unit | 2025 |
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 |
|---|---|---|
| SHANGHAI NO. 2 MEDICAL COLLEGE DUHANG MEDICAL EQUIPMENT FACTORYFDA reg. 3037012186 | Shanghai, China | Contract manufacturer, Foreign exporter, Manufacturer |
Other names on FDA records
Shanghai No.2 Medical College Duhang Medical Equipment Factory
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092805). 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.