Manufacturer registered with FDA
Taizhou Xinkang Medical Materials Co., Ltd
Taizhou, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 750 registrations outside the US
- Establishments
- 1China
Registered in 7 markets
Where regulators' registries name Taizhou Xinkang Medical Materials 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 | Taizhou Xinkang Medical Materials Co., Ltd | 2 device types | — | Below |
| European Union | EUDAMED | Registration holder | Taizhou Xinkang Medical Materials Co., LtdTaizhou Xinkang Medical Materials Co., Ltd. | 30 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Taizhou Xinkang Medical Materials Co Ltd | 11 | 2006–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Taizhou Xinkang Medical Materials Co., Ltd.TAIZHOU XINKANG MEDICAL MATERIALS, · Taizhou Xinkang Medical Materials Co,. Ltd | 4 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Taizhou Xinkang Medical Materials Co., Ltd. | 3 | 2023–2026 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | TAIZHOU XINKANG MEDICAL MATERIALS CO., LTD | 1 | 2025–2025 | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | TAIZHOU XINKANG MEDICAL MATERIALS 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 Taizhou Xinkang Medical Materials 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 | 2014 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss | 2026 |
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 |
|---|---|---|
| TAIZHOU XINKANG MEDICAL MATERIALS CO., LTDFDA reg. 3005460813 | Taizhou Jiangsu, China | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045001). 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.