Registered with FDA
RFX+CARE Manufacturing Co., Ltd.
Shaoxing, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7235 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name RFX+CARE Manufacturing 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 | Lister | RFX+CARE Manufacturing Co., Ltd. | 1 device types | — | Below |
| European Union | EUDAMED | Registration holder | RFX+CARE Manufacturing Co., Ltd. | 161 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | RFX+CARE Manufacturing Co., Ltd. | 53 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | RFX+CARE MANUFACTURING CO. LTD.RFX+CARE MANUFACTURING CO., LTD | 12 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | RFX+CARE MANUFACTURING CO., LTD. | 5 | 2024–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | RFX+Care Manufacturing Co Ltd | 3 | 2010–2013 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RFX+CARE Manufacturing Co., LTD | 1 | 2018–2018 | 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 RFX+CARE Manufacturing 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | RFX+CAREToothbrush | 2013 |
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 |
|---|---|---|
| RFX+CARE MANUFACTURING CO., LTD.FDA reg. 3007307589 | Shaoxing Zhejiang, China | Foreign exporter, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027255). 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.