Manufacturer registered with FDA
Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd.
Tonglu, 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
- 451 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Hangzhou Tonglu Shikonghou 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 | Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Hangzhou Tonglu Shikonghou Medical Instrument Co.,Ltd.Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. · HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENT CO.,LTD · +2 | 31 | 2011–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENT CO., LTD. | 19 | 2022–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Hangzhou Tonglu Shikonghou Medical Instrument Co Ltd | 1 | 2013–2013 | 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 Hangzhou Tonglu Shikonghou 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 |
|---|---|---|---|---|
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | — | 2014 |
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 |
|---|---|---|
| HANGZHOU TONGLU SHIKONGHOU MEDICAL INSTRUMENT CO., LTDFDA reg. 3007675948 | Hangzhou Zhejiang, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046214). 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.