Manufacturer registered with FDA
Tonglu Wanhe Medical Instrument Co., Ltd.
Hangzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 314 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Tonglu Wanhe Medical Instrument 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 | Tonglu Wanhe Medical Instrument Co., Ltd. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Tonglu WANHE medical instrument Co.,Ltd.Tonglu WANHE Medical Instrument Co.,Ltd · Tonglu Wanhe Medical Instrument Co.,Ltd · +1 | 10 | 2019–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TONGLU WANHE MEDICAL INSTRUMENT CO., LTD. | 4 | 2020–2023 | 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 Tonglu Wanhe Medical Instrument 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 |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | — | 2013 |
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 |
|---|---|---|
| TONGLU WANHE MEDICAL INSTRUMENT CO., LTD.FDA reg. 3010611926 | Hangzhou Zhejiang, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045600). 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.