Varian Medical Systems China Co., Ltd.

Manufacturer and brand owner in Beijing, China. 2 device types, 1 product catalogued.

Registry build 21.09.26

Varian Medical Systems China Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Accelerator, Linear, Medical, System, Planning, Radiation Therapy Treatment. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2020.

2device types registered with the FDA
1product

Registration

FDA registration record for Varian Medical Systems China Co., Ltd.
Status Registered
Registration expires 2026
Registration number 3007791541
FEI number 3007791541
DUNS 545295284
Establishment type Manufacturer

Chinese Registration

Chinese company register details for Varian Medical Systems China Co., Ltd.
Chinese legal name 瓦里安医疗设备(中国)有限公司
Source export sales certificate, Beijing medical products administration

Location

Address of Varian Medical Systems China Co., Ltd.
City Beijing
Province Beijing
Address No. 8 Yuncheng Street
Postal code 100176
Country China

What It Makes

Device types Varian Medical Systems China Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accelerator, Linear, Medical Class 2 Halcyon Ethos Radiotherapy System, Halcyon, Ethos Radiotherapy System, Halcyon, Ethos Radiotherapy System (5) 2020 8
System, Planning, Radiation Therapy Treatment Class 2 Halcyon, Ethos Radiotherapy System 2020 5

Own-Brand Listings

Devices catalogued by Varian Medical Systems China Co., Ltd.
Product Code Catalogue numbers
Halcyon IYE 2

Clearances

No clearance names Varian Medical Systems China Co., Ltd. as applicant. 4 are held by another company 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 Varian Medical Systems China Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K252977 2026-01-21 IYE Traditional Varian Medical Systems, Inc
K232113 2023-11-03 IYE Traditional Varian Medical Systems, Inc
K222941 2023-01-17 IYE Traditional Varian Medical Systems, Inc
K192377 2020-02-10 IYE Traditional Varian Medical Systems, Inc

From the Company

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

Information published by Varian Medical Systems China Co., Ltd.
Main products Medical linear accelerators, Radiation therapy equipment, Brachytherapy systems
Certifications CE, FDA, ISO
Export markets 90 countries

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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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