Manufacturer registered with FDA
Winner Medical Co Ltd
Shenzhen, China. Lists 1 dental device type with FDA across 2 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 14366 registrations outside the US
- Establishments
- 2China
Registered in 14 markets
Where regulators' registries name Winner Medical 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 | Winner Medical Co Ltd | 1 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Winner Medical Co., Ltd. | 102 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Winner Medical Co., Ltd. | 92 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | WINNER MEDICAL CO. LTDWINNER MEDICAL CO., LTD · WINNER MEDICAL (JIAYU) CO LTD · +1 | 49 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Winner Medical Co Ltd | 45 | 2014–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Winner Medical Co., Ltd. | 28 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | WINNER MEDICAL CO., LTD.Winner Medical Co., Ltd. | 20 | 2015–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Winner Medical Co., LtdWinner Medical Co., Ltd. · Winner Medical Co, Ltd | 11 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Winner Medical Co., Ltd. | 5 | 2025–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Winner Medical Co., LtdWinner Medical Co., Ltd. · (주)세종헬스케어^거림테크(주)^Winner Medical Co., Ltd | 5 | 2013–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | WINNER MEDICAL CO. LTD. | 3 | 2021–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Winner Medical Co., Ltd. | 3 | 2018–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Winner Medical Co., Ltd. | 2 | 2025–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Winner Medical 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 Winner Medical 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 |
|---|---|---|---|---|
| Roll CottonEFN · Class 1 | — | Maker | Cotton Roll, Cotton Ball | 2002 |
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 |
|---|---|---|
| Winner Medical (Jiayu) Co., Ltd.FDA reg. 3008132238 | Jiayu Hubei, China | Contract manufacturer |
| WINNER MEDICAL CO., LTD.FDA reg. 3030067857 | SHENZHEN Guangdong, China | Foreign exporter, Specification developer |
Other names on FDA records
Winner Medical (Jiayu) Co. Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9012349). 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.