HomeChinaSonostar Technologies Co., Limited

Sonostar Technologies Co., Limited

China · 广州 · www.sonostar.cn
✓ Record-verifiedregistrations found in 12 marketsEU SRN CN-MF-000030303Unified social credit code 91440116574031770P

This company holds 4 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 11 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
4China registrations
Class II 4
as of 2026-09-04
EUEuropean UnionEUDAMED
46UDI-DI device records
Class IIa 46
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class IIa 3
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
1 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
8registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 Union46 raw hits, 0 excluded, 46 confirmed
United States3 registration records, 3 510(k), 0 PMA
China4 certificates (Class III 0 / II 4 / I 0), as of 2026-09-04
United Kingdom3 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD. · GUANGZHOU SONOSTAR TECHNOLOGIES CO., LTD · GUANGZHOU SONOSTAR TECHNOLOGIES CO

Regulatory identity

EU manufacturer SRN
CN-MF-000030303
EU authorised representative
SUNGO Europe B.V.
UK responsible person
SUNGO Certification Company Limited
Unified social credit code
91440116574031770P
Exhibition record
CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Company information

Country
China
Social-insurance enrolees
38
Annual revenue
RMB 100–500M
Website
www.sonostar.cn
Product categories
妇产科、辅助生殖和避孕器械眼科器械手术器械医用成像器械

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
2011-05-16
Registered capital
CNY 10,000,000
Paid-in capital
CNY 10,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Research and experimental development
Last approval date
2026-01-30
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseGazelle enterpriseInnovative SME
Listing
Listed on a regional equity 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

12017 · K171926
12018 · K172750
12022 · K211321

FDA listed device types

System, Imaging, Pulsed Doppler, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1

Registration details (sample)

MarketIdentifierNameClass / date
CN粤械注准20222060415掌上彩色多普勒超声显像仪Class II
CN粤械注准20172060326全数字彩色多普勒超声诊断系统Class II
CN粤械注准20162061593全数字超声显像诊断仪Class II
CN粤械注准20162061592全数字超声显像诊断仪Class II
EU06970672751385Wireless Probe Type Ultrasound ScannerClass IIa
EU06970672751378Wireless Probe Type Ultrasound ScannerClass IIa
EU06970672751361Wireless Probe Type Ultrasound ScannerClass IIa
EU06970672751354Wireless Probe Type Ultrasound ScannerClass IIa
UK40761Wireless Probe Type Ultrasound ScannerClass IIa
UK40768UProbe-L5PCClass IIa
UK60924WIRELESS ULTRASOUND PROBEClass IIa
USK211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)2022-10-13
USK172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)2018-02-28
USK171926C5 Diagnostic Ultrasound System2017-10-27
BR81535520003Família de Ultrassom Portátil com DoppleRClass II

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