Manufacturer registered with FDA
Hynaut Health Technology Co., LTD.
Qingdao, 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
- 467 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Hynaut Health Technology 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 | Hynaut Health Technology Co., LTD. | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Hynaut Health Technology Co., LTD | 61 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hynaut Health Technology Co., LTD | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HYNAUT HEALTH TECHNOLOGY CO., LTD. | 2 | 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 Hynaut Health Technology 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 | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Floss pick | 2019 |
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 |
|---|---|---|
| Hynaut Health Technology Co., LTD.FDA reg. 3008808560 | Qingdao Shandong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040387). 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.