Manufacturer registered with FDA
Jiangsu Saikang Medical Equipment Co., Ltd
Zhangjiagang, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 12121 registrations outside the US
- Establishments
- 1China
Registered in 12 markets
Where regulators' registries name Jiangsu Saikang 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 | Jiangsu Saikang Medical Equipment Co., Ltd | 2 device types | — | Below |
| Colombia | INVIMA | Registration holder | JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD.JIANGSU SAIKANG MEDICAL EQUIPMENT CO.,LTDA | 38 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD. | 27 | 2018–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Jiangsu Saikang Medical Equipment Co.,Ltd | 21 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | JIANGSU SAIKANG MEDICAL EQUIPMENT CO. LTDJIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD. | 11 | 2023–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Jiangsu Saikang Medical Equipment Co.,LTD.Jiangsu Saikang Medical Equipment Co., Ltd. | 10 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Jiangsu Saikang Medical Equipment Co.,Ltd.JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD | 4 | 2016–2019 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Jiangsu Saikang Medical Equipment Co. ,Ltd. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Jiangsu Saikang Medical Equipment Co Ltd | 2 | 2016–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Jiangsu Saikang Medical Equipment Co., Ltd.Jiangsu Saikang Medical Equipment Co.,Ltd | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTD. | 2 | 2019–2021 | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | JIANGSU SAIKANG MEDICAL EQUIPMENT Co.,LTD | 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 Jiangsu Saikang 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 |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Electric suction unitManual suction unitSputum suction unit | 2017 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Dental 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 |
|---|---|---|
| JIANGSU SAIKANG MEDICAL EQUIPMENT CO., LTDFDA reg. 3010373263 | Zhangjiagang Jiangsu, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043618). 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.