Manufacturer registered with FDA
Xinhua Surgical Instrument Co.,Ltd.
ZIBO SHANDONG, China. Lists 30 dental device types with FDA across 1 registered establishment.
- Device types listed
- 30
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 614 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Xinhua Surgical 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 | Xinhua Surgical Instrument Co.,Ltd. | 30 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Xinhua Surgical Instrument Co.,Ltd. | 7 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | XINHUA SURGICAL INSTRUMENT CO., LTD. | 4 | 2017–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | XINHUA SURGICAL INSTRUMENT CO., LTD. | 1 | 2026–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | XINHUA SURGICAL INSTRUMENT CO., LTD | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Xinhua Surgical 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 Xinhua Surgical Instrument Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
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 |
|---|---|---|
| XINHUA SURGICAL INSTRUMENT CO. LTD.FDA reg. 3005440795 | ZIBO Shandong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9079079). 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.