Manufacturer registered with FDA
Shanghai Xingyu Medical Equipment Co.,Ltd
SHANGHAI, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 721 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Shanghai Xingyu Medical Equipment Co.,Ltd 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 Xingyu Medical Equipment Co.,Ltd | 3 device types | — | Below |
| Taiwan | TFDA | Manufacturer | SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTDSHANGHAI XINGYU MEDICAL EQUIPMENT CO., LTD · Shanghai Xing Yu Medical Equipment Co., Ltd. | 8 | 2010–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD.SHANGHAI XING YU MEDICALEQUIPMENT CO., LTD. | 4 | 2023–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shanghai Xingyu Medical Equipment Co.,Ltd | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Shanghai Xing Yu Medical Equipment Co., LTDShanghai Xing Yu Medical Equipment Co., Ltd. | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Shanghai Xing Yu Medical Equipment Co., Ltd. | 2 | 2025–2025 | 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 Xingyu Medical Equipment Co.,Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points | 2007 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2007 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Dental Files | 2012 |
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 XING YU MEDICAL EQUIPMENT CO., LTD.FDA reg. 3006550196 | SHANGHAI, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9101730). 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.