Manufacturer registered with FDA
Zhuhai Siger Medical Equipment Co Ltd
Zhuhai, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12015–2015
- Markets registered in
- 1039 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Zhuhai Siger 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 | Zhuhai Siger Medical Equipment Co Ltd | 1 clearances | 2015–2015 | Below |
| Serbia | ALIMS | Manufacturer | Zhuhai Siger Medical Equipment Co., Ltd. | 8 | 2023–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Zhuhai Siger Medical Equipment Co Ltd | 5 | 2017–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ZHUHAI SIGER MEDICAL EQUIPMENT CO. LTDZHUHAI SIGER MEDICAL EQUIPMENT CO., LTD | 5 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ZHUHAI SIGER MEDICAL EQUIPMENT CO., LTD. | 5 | 2014–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Zhuhai Siger Medical Equipment Co., Ltd. | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Zhuhai Siger Medical Equipment Co., Ltd.ZHUHAI SIGER MEDICAL EQUIPMENT CO. LTD · ZHUHAI SIGER MEDICAL EQUIPMENT CO., LTD | 4 | 2014–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Zhuhai Siger Medical Equipment Co., Ltd. | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zhuhai Siger Medical Equipment Co., Ltd | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | ZHUHAI SIGER MEDICAL EQUIPMENT CO.,Zhuhai Siger Medical Equipment Co., Ltd | 2 | 2018–2020 | 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 Zhuhai Siger 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 |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Dental Unit U300 U500 | 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 |
|---|---|---|
| ZHUHAI SIGER MEDICAL EQUIPMENT CO LTDFDA reg. 3009797758 | Zhuhai Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048933). 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.