Manufacturer registered with FDA
Jiangsu Trausim Medical Instrument Co.,Ltd.
Changzhou, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12014–2014
- Markets registered in
- 38 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Jiangsu Trausim 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 | Jiangsu Trausim Medical Instrument Co.,Ltd. | 1 clearances | 2014–2014 | Below |
| European Union | EUDAMED | Manufacturer | Jiangsu Trausim Medical Instrument Co., Ltd. | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Jiangsu Trausim Medical Instrument Co Ltd | 2 | 2020–2025 | 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 Jiangsu Trausim 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Trausim Dental Implant System | 2015 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Trausim Dental Implant System | 2015 |
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 |
|---|---|---|
| JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.FDA reg. 3011587077 | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048519). 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.