Manufacturer registered with FDA
Yangzhou Sinje Biotechnology Co.,Ltd
Yangzhou, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Yangzhou Sinje Biotechnology 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 | Yangzhou Sinje Biotechnology Co.,Ltd | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Yangzhou Sinje Biotechnology Co.,Ltd | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Yangzhou Sinje Biotechnology Co Ltd | 1 | 2026–2026 | 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 Yangzhou Sinje Biotechnology 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 |
|---|---|---|---|---|
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Cleanser, Denture, over the counter | 2025 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush, Manual | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | pick; Toothbrush Sonic, Battery Powered | 2025 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss, Dental, dental flosser | 2025 |
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 |
|---|---|---|
| YANGZHOU SINJE BIOTECHNOLOGY CO.,LTDFDA reg. 3042277637 | Yangzhou Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094373). 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.