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UNITED IMAGING

China · Shanghai · ha.uim-solution.com/en/index

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000030896Unified social credit code 91310114570796872F

This company holds 115 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 10 overseas markets. EU UDI-DI records ≥18, the first 300 verified individually.

Registrations by market

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

CNChinaNMPA

115China registrations

Class I 4Class II 26Class III 85

as of 2026-09-04

EUEuropean UnionEUDAMED

≥18UDI-DI device records

Class IIa 18

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

15listed device types

Class I 0Class II 15Class III 0

plus 104 registration records and 92 510(k)

UKUnited KingdomMHRA PARD

28registered device records

Class IIa 15Class IIb 13

BRBrazilANVISA

19registered devices

Class II 19

40 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

8 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

33device registrations

CLASS B 17CLASS C 16

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

20active ARTG entries

IIa 9IIb 11

HKHong KongMDACS

17valid listings

Class II 5Class III 12

ILIsraelAMAR

16registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 2Class 2b 2

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 Union6,577 raw hits, 82 excluded, 18 confirmed. Large result set — only the first 300 verified

United States104 registration records, 92 510(k), 0 PMA, 103 excluded

China115 certificates (Class III 85 / II 26 / I 4), as of 2026-09-04

United Kingdom28 confirmed, 16 excluded

Brazil19 confirmed, 17 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada0 confirmed, 8 excluded

Manufacturer names merged into this page: SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. · Wuhan United Imaging Healthcare Co.,Ltd. · United Imaging Healthcare North America, Inc · SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. · SHANGHAI UNITED IMAGING HEALTHCARE CO. LTD. · UNITED IMAGING BRAZIL EQUIPAMENTOS MÉDICOS LTDA

Regulatory identity

EU manufacturer SRN: CN-MF-000030896
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Obelis UK Ltd
Unified social credit code: 91310114570796872F
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2011-03-21
Registered capital: CNY 824,157,988
Paid-in capital: CNY 824,157,988
Legal form: Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2025-10-31
Recognitions: National High-Tech EnterpriseGazelle enterpriseAbove-designated-size industrial enterprise
Listing: Listed on the STAR Market

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

12015

142018

102019

102020

42021

32022

112023

142024

172025

82026

FDA listed device types

showing 8 of 15

Coil, Magnetic Resonance, Specialty 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1System, Tomography, Computed, Emission 1System, Nuclear Magnetic Resonance Imaging 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263061819	X射线计算机体层摄影设备	Class III
CN	国械注准20263061818	X射线计算机体层摄影设备	Class III
CN	国械注准20263061479	磁共振成像系统	Class III
CN	国械注准20263060754	医用血管造影X射线机	Class III
EU	06974829931095	—	Class IIa
EU	06974829931088	—	Class IIa
EU	06974829931071	—	Class IIa
EU	06974829931064	—	Class IIa
UK	40868	Angiography X-ray Image Processing Software	Class IIa
UK	40935	Mammography Image Post-processing Software	Class IIa
UK	37618	Computed Tomography X-ray System	Class IIb
US	K261427	uMI Panvivo (uMI Panvivo M)	2026-07-28
US	K260113	uMR Astra	2026-05-22
US	K253720	uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite	2026-05-21
BR	81464759053	Sistema de imagem por ressonância magnética	Class II
BR	81464750218	Sistema de gerenciamento e processamento de imagens médicas	Class II
BR	81464759084	Sistema de imagem por ressonância magnética	Class II