Data / Medical devices / China / Jiangsu Trausim Medical Instrument Co.,ltd.
Jiangsu Trausim Medical Instrument Co.,ltd.: FDA-registered device maker in Changzhou Jiangsu, China, 1 510(k) clearance
Jiangsu Trausim Medical Instrument Co.,ltd. is registered with the FDA (registration 3011587077) in Changzhou Jiangsu, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 12, 2014. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011587077
- Address
- No.18 Jincheng Road Wujin Economic Development Zone, Changzhou Jiangsu, China, 213149
- Owner or operator
- Jiangsu Trausim Medical Instrument Co.,Ltd. (10048519)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 22, 2015
- Registered through
- 2026
- Brand names listed
- Aesthetic Management Partners, Estar Technologies, Traudent, Trausim, Trausim Dental Implant System, Win Union
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | QBV | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2014 | K140202 | TRAUSIM DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Jiangsu Trausim Medical Instrument | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Updated December 12, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.