Manufacturer registered with FDA
Hunan Accurate Bio-Medical Technology Co., Ltd.
Changsha, 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
- 1027 registrations outside the US
- Establishments
- 1China
Registered in 10 markets
Where regulators' registries name Hunan Accurate Bio-Medical 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 | Hunan Accurate Bio-Medical Technology Co., Ltd. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Hunan Accurate Bio-Medical Technology Co.,Ltd. | 9 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hunan Accurate Bio-Medical Technology Co., Ltd | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD | 3 | 2024–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Hunan Accurate Bio-Medical Technology Co Ltd | 2 | 2022–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | HUNAN ACCURATE BIO MEDICAL TECHNOLOGY CO. LTDHunan Accurate Bio-Medical Technology Co., Ltd. | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hunan Accurate Bio-Medical Technology Co., Ltd.Hunan Accurate Bio-Medical Technology Co.,Ltd | 2 | 2023–2023 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Hunan Accurate Bio-Medical Technology Co., Ltd. | 1 | 2024–2024 | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | Hunan Accurate Bio-Medical Technology Co., Ltd. | 1 | 2022–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Hunan Accurate Bio-Medical Technology 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 Hunan Accurate Bio-Medical 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Portable Oral Irrigator (model: TH2A3, TH2D4, TH2C3, TH2F3) | 2021 |
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 |
|---|---|---|
| HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3011353016 | Changsha Hunan, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048204). 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.