Manufacturer registered with FDA
Hantech Medical Device Co., Ltd.
Cixi, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 923 registrations outside the US
- Establishments
- 1China
Registered in 9 markets
Where regulators' registries name Hantech Medical Device 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 | Hantech Medical Device Co., Ltd. | 5 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Hantech Medical Device Co., Ltd. | 8 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hantech Medical Device Co., Ltd. | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HANTECH MEDICAL DEVICE CO., LTD | 3 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Hantech Medical Device Co Ltd | 2 | 2023–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Hantech Medical Device CO., LTD | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Hantech Medical Device Co., Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HANTECH MEDICAL DEVICE CO., LTD. | 1 | 2026–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hantech Medical Device Co., Ltd. | 1 | 2021–2021 | 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 Hantech Medical Device 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 |
|---|---|---|---|---|
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Purcha Points | 2020 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points | 2023 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | EndoActivator Tips | 2022 |
| Tube Impression and MatrixKCQ · Class 1 | — | Maker | Mixing Tips | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Dental FoilMouthguard | 2022 |
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 |
|---|---|---|
| HANTECH MEDICAL DEVICE CO., LTD.FDA reg. 3015060216 | Cixi Zhejiang, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058745). 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.