Jiangsu Trausim Medical Instrument Co., Ltd.

Registered establishment in Changzhou, Jiangsu, China. 3 device types, 1 clearance.

Registry build 21.09.26

Jiangsu Trausim Medical Instrument Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Implant, Endosseous, Root-Form, Abutment, Implant, Dental, Endosseous and 1 other device type. Its earliest product listing with the FDA dates from 2015.

3device types registered with the FDA
1510(k) clearance

Registration

FDA registration record for Jiangsu Trausim Medical Instrument Co., Ltd.
Registered name JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.
Status Registered
Registration expires 2026
Registration number 3011587077
FEI number 3011587077
Establishment type Contract manufacturer, Manufacturer

Location

Address of Jiangsu Trausim Medical Instrument Co., Ltd.
City Changzhou
Province Jiangsu
Address No.18 Jincheng Road
Postal code 213149
Country China

What It Makes

Device types Jiangsu Trausim Medical Instrument Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Abutment, Implant, Dental, Endosseous Class 2 Trausim Dental Implant System 2015 15
Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate Class 1 Win Union, Trausim, Aesthetic Management Partners, Estar Technologies, Traudent 2026 5
Implant, Endosseous, Root-Form Class 2 Trausim Dental Implant System 2015 7

Clearances

510(k) clearances naming Jiangsu Trausim Medical Instrument Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K140202 2014-12-12 DZE Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Jiangsu Trausim Medical Instrument Co., Ltd.
Main products Dental implants (NT, BL/BLE, TL/TLE systems), Surgical instruments, A-PRF (autologous platelet-rich fibrin)
Export markets China, global market

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

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