Manufacturer registered with FDA
Huaian Tisurg Medical Instruments Co., Ltd.
Huaian City, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Huaian Tisurg Medical Instruments 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 | Huaian Tisurg Medical Instruments Co., Ltd. | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | HUAIAN TISURG MEDICAL INSTRUMENTS CO., LTD. | 3 | 2014–2020 | Pure Global AI |
| South Korea | MFDS | Manufacturer | HUAIAN TISURG MEDICAL INSTRUMENTS CO.,LTDHuaian Tisurg Medical Instruments Co.,Ltd | 2 | 2014–2022 | 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 Huaian Tisurg Medical Instruments 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 |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Custom Tray ResinH-0600 ResinIBT Flex ResinIBT Resin | 2020 |
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 |
|---|---|---|
| HUAIAN TISURG MEDICAL INSTRUMENTS CO., LTD.FDA reg. 3007334784 | Huaian City Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027346). 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.