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Varex Imaging

✓ Record-verifiedregistrations found in 8 marketsEU SRN US-MF-000028124Unified social credit code 913202053309293659

This company holds 23 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia — 7 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

23China registrations

Class II 23

as of 2026-09-04

EUEuropean UnionEUDAMED

153UDI-DI device records

Class IIa 5Class IIb 148

USUnited StatesFDA openFDA

4listed device types

Class I 2Class II 2Class III 0

plus 10 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class IIa 1Class IIb 3

BRBrazilANVISA

7registered devices

Class II 7

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class III 3

15 including historic records

TWTaiwanTFDA

5valid device licences

Class I 5

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union153 raw hits, 0 excluded, 153 confirmed

United States10 registration records, 7 510(k), 0 PMA

China23 certificates (Class III 0 / II 23 / I 0), as of 2026-09-04

United Kingdom4 confirmed, 0 excluded

Brazil7 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: Varex Imaging Corporation · Varex Imaging Nederland B.V. · Varex Imaging Philippines Inc. · Varex Imaging Equipment (China) Co., LTD · VAREX IMAGING CORPORATION · VAREX IMAGING AMERICAS CORPORATION

Regulatory identity

EU manufacturer SRN: US-MF-000028124
EU authorised representative: Arazy Group GmbH
UK responsible person: Medes Ltd.
Unified social credit code: 913202053309293659
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2015-03-02
Registered capital: CNY 83,000,000
Paid-in capital: CNY 83,000,000
Legal form: Limited liability company (wholly owned by a foreign corporation)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2026-02-12
Recognitions: Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

22017 · K172951

22018 · K183212

22019 · K193238

12026 · K253103

FDA listed device types

Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Fluoroscopic, Image-Intensified 1Generator, High-Voltage, X-Ray, Diagnostic 1Assembly, Tube Housing, X-Ray, Diagnostic 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	苏械注准20252061130	X射线管组件	Class II
CN	苏械注准20252061126	X射线管组件	Class II
CN	苏械注准20242060988	X射线管组件	Class II
CN	苏械注准20192061473	X射线管组件	Class II
EU	00854344007801	Nexus DR	Class IIb
EU	08718755004250	Varex Imaging	Class IIb
EU	08718755004120	Varex Imaging	Class IIb
EU	08718755004106	Varex Imaging	Class IIb
UK	61108	Flat Panel Imaging components - Fluoroscopic panels	Class IIa
UK	40847	Digital X-ray Imaging System	Class IIb
UK	40847	Digital X-ray Imaging System	Class IIb
US	K253103	Nexus DRF Digital X-ray Imaging System	2026-05-29
US	K193238	Nexus DR Digital X-Ray Imaging System (with vSharp)	2019-12-20
US	K190146	Nexus DR Digital X-ray Imaging System	2019-03-08
BR	10332650015	DIGITALIZADOR DE IMAGENS RADIOGRÁFICAS, MARCA VARIAN	Class II
BR	10332650017	DETECTOR DIGITAL DE RAIOS-X	Class II
BR	10332659002	Sistema de Aquisição de Imagens Nexus DR	Class II
CA	477	GOLDONE FLUOROSCOPIC IMAGING SYSTEMS	Class III
CA	1380	MAGELLAN FLUOROSCOPIC IMAGING SYSTEM	Class III
CA	66001	PLATINUMONE FLUOROSCOPIC IMAGING SYSTEM	Class III

Varex Imaging

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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