Manufacturer registered with FDA
Medwell Medical Products Co., Ltd.
Dean County, 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
- 11397 registrations outside the US
- Establishments
- 1China
Registered in 11 markets
Where regulators' registries name Medwell Medical Products 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 | Medwell Medical Products Co., Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | MEDWELL MEDICAL PRODUCTS CO., LTDMEDWELL MEDICAL PRODUCTS CO, LTD · MEDWELL MEDICAL PRODUCTS CO., LTD. | 329 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Medwell Medical Products Co., Ltd. | 39 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDWELL MEDICAL PRODUCTS CO LTD | 11 | 2014–2020 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDWELL MEDICAL PRODUCTS CO., LTD. | 4 | 2017–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MEDWELL MEDICAL PRODUCTS CO.LTD | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Medwell Medical Products Co., LtdMedwell Medical Products Co., Ltd. | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Medwell Medical Products Co., Ltd.Medwell Medical Products CO.,LTD | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Medwell Medical Products Co Ltd | 2 | 2025–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Medwell Medical Products Co., Ltd | 1 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Medwell Medical Products Co., Ltd, | 1 | 2024–2024 | 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 Medwell Medical Products 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 | MEDWELL MEDICAL PRODUCTS CO.,LTD | 2008 |
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 |
|---|---|---|
| MEDWELL MEDICAL PRODUCTS CO., LTD.FDA reg. 3007360701 | Jiujiang City Jiangxi, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027483). 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.