Jiangxi Medex Technology Co., Ltd.

Manufacturer and brand owner in Xinfeng, Jiangxi, China. 1 device type, 3 products catalogued, 2 clearances.

Registry build 21.09.26

Jiangxi Medex Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.

1device type
3products catalogued under its own name
2510(k) clearances

Registration

FDA registration record for Jiangxi Medex Technology Co., Ltd.
Registered name JIANGXI MEDEX TECHNOLOGY CO.,LTD
Status Registered
Registration expires 2026
Registration number 3013529876
FEI number 3013529876
DUNS 544457636
Establishment type Manufacturer, Exporter

Chinese Registration

Chinese company register details for Jiangxi Medex Technology Co., Ltd.
Chinese legal name 江西麦帝施科技有限公司
Unified social credit code 91360722MA35KWR05X
Source NMPA UDI database

Location

Address of Jiangxi Medex Technology Co., Ltd.
City Xinfeng
Province Jiangxi
Address ChengXin Avenue,Xinfeng Industrial Area
Postal code 330104
Country China

What It Makes

Device types Jiangxi Medex Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Powered Laser Surgical Instrument Class 2 Diode Laser System (LaserPro D980, LaserPro D810, Aurolance 980, Aurolance 810, Aurolance AM), SACSII, Independent Fiber Coolant System, SACS,Independent Fiber Coolant System, SLT Select Fiber Delivery System and Contact Tips, LaserPro Diode Surgical Laser System 2022 92

Own-Brand Listings

Devices catalogued by Jiangxi Medex Technology Co., Ltd.
Product Code Catalogue numbers
SLT GEX 2
LaserPro GEX 1
medex GEX 1

Clearances

2 clearances name Jiangxi Medex Technology Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Jiangxi Medex Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K243141 2024-12-26 GEX Traditional This company
K243121 2024-12-22 GEX Traditional This company
K082721 2008-10-28 GEX Traditional Photo Medex, Inc.
K980156 1998-02-27 GEX Traditional Surgical Laser Technologies, Inc.
K952754 1995-07-31 GEX Traditional Surgical Laser Technologies, Inc.

From the Company

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

Information published by Jiangxi Medex Technology Co., Ltd.
Employees 100-500
Main products Semiconductor Laser Treatment Systems, Medical Laser Fiber, Laser Equipment, Laser Probes
Export markets International (participates in CMEF and ASLMS)

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer