HomeChinaShenzhen SONTU Medical Imaging Equipment Co.,LTD

Shenzhen SONTU Medical Imaging Equipment Co.,LTD

China · 深圳 · www.sontu.com.cn
✓ Record-verifiedregistrations found in 4 marketsEU SRN CN-MF-000006958Unified social credit code 914403006894188017

This company holds 28 NMPA certificates in China and has registrations in European Union, United States, Brazil — 3 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
28China registrations
Class I 1Class II 27
as of 2026-09-04
EUEuropean UnionEUDAMED
2UDI-DI device records
Class IIb 2
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 Union2 raw hits, 0 excluded, 2 confirmed
United States0 registration records, 1 510(k), 0 PMA
China28 certificates (Class III 0 / II 27 / I 1), as of 2026-09-04
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: SHENZHEN SONTU MEDICAL IMAGING EQUIPMENT CO., LTD

Regulatory identity

EU manufacturer SRN
CN-MF-000006958
EU authorised representative
MedNet EC-REP GmbH
Unified social credit code
914403006894188017
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
115
Annual revenue
RMB 100–500M
Website
www.sontu.com.cn
Product categories
医用成像器械

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2009-06-10
Registered capital
CNY 32,424,500
Paid-in capital
CNY 32,424,500
Legal form
Limited liability company
Industry classification
Repair of metal products, machinery and equipment
Last approval date
2025-11-17
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseSRDI SMEGazelle enterpriseSME Association AAA credit ratingInnovative SME
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.

FDA 510(k) clearances by year

12025 · K242499

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20252061098数字化透视摄影X射线机Class II
CN粤械注准20232060647移动式C形臂X射线机Class II
CN粤械注准20222061035数字化摄影X射线机Class II
CN粤械注准20222060933X射线平板探测器Class II
EU06973074990055Class IIb
EU06973074990031Class IIb
USK242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))2025-01-06
BR80117589039Wireless Detector Digital Plano de Raios-XClass II

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