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Neusoft Medical Systems Co., Ltd.

✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000011819Unified social credit code 91210112702087542R

This company holds 101 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 11 overseas markets.

Registrations by market

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

CNChinaNMPA

101China registrations

Class II 52Class III 49

as of 2026-09-04

EUEuropean UnionEUDAMED

39UDI-DI device records

Class IIa 4Class IIb 35

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 6 registration records and 28 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIb 2

BRBrazilANVISA

6registered devices

Class II 6

13 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

7device registrations

CLASS B 7

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

10active ARTG entries

IIa 2IIb 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 3Class 2b 4

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 Union40 raw hits, 1 excluded, 39 confirmed

United States6 registration records, 28 510(k), 0 PMA

China101 certificates (Class III 49 / II 52 / I 0), as of 2026-09-04

United Kingdom2 confirmed, 0 excluded

Brazil6 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: NEUSOFT MEDICAL SYSTEMS CO., LTD. · NEUSOFT POSITRON MEDICAL SYSTEMS CO.,LTD. · NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD. · NEUSOFT MEDICAL SYSTEMS CO LTD · NEUSOFT MEDICAL SYSTEMS CO. LTD · Neusoft Medical Systems Co. Ltd.

Regulatory identity

EU manufacturer SRN: CN-MF-000011819
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited
Unified social credit code: 91210112702087542R
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 1998-03-06
Registered capital: CNY 2,235,025,906
Paid-in capital: CNY 2,235,025,906
Industry classification: Special-purpose equipment manufacturing
Last approval date: 2024-09-18
Recognitions: National High-Tech EnterpriseRecognised enterprise technology centreTechnology Innovation Demonstration EnterpriseAbove-designated-size industrial enterprise
Listing: Registered on a regional equity market (not traded)

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.

Registration details (sample)

Market	Identifier	Name	Class / date
CN	国械注准20263061196	X射线计算机体层摄影设备	Class III
CN	国械注准20263060927	X射线计算机体层摄影设备	Class III
CN	国械注准20263060771	X射线计算机体层摄影设备	Class III
CN	国械注准20263060763	X射线计算机体层摄影设备	Class III
EU	06970167442279	NeuViz Spire Max	Class IIb
EU	06970167444006	NeuViz Spire Peak	Class IIb
EU	06970167442286	NeuViz Spire Max+	Class IIb
EU	06970167443351	NeuViz Prime Max+	Class IIb
UK	37618	Multi-Slice CT Scanner System	Class IIb
UK	37623	Medical Angiography X-ray System	Class IIb
US	K230220	NeuViz 128 Multi-Slice CT Scanner System	2023-10-11
US	K171198	NeuViz 16 Essence Multi-slice CT Scanner System	2017-12-07
US	K171201	NeuViz Prime Multi-slice CT Scanner System	2017-09-13
BR	80059529003	Sistema de Ressonância Magnética Médica	Class II
BR	10216719022	Sistema de Ultrassom 3300	Class II
BR	80059529002	Sistema de aquisição de imagens por ressonância magnética NeuMR 1.5T	Class II
CA	87829	POSITRON EMISSION TOMOGRAPHY (PET) SCANNER	Class II

Neusoft Medical Systems Co., Ltd.

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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