Company information: registration, licences and patents
Guangzhou Sonostar Information Technology Co., Ltd. was founded in 2011 and focuses on the development, manufacture and sale of ultrasound diagnostic and imaging equipment; complete systems are assembled, calibrated and factory-tested in our own plant in Zengcheng. This page lists the business registration details, the 11 production and operating licences, the 4 medical device registration certificates and the 37 granted patents, each with its number and validity period, so that every item can be checked independently on the regulator's platform.
Who we are
Four figures, and each one can be traced to a source further down this page.
Offices and production at one address, whole building in use
Head office and production site
The head office and production site are at Building 7, Zhongjiao Zhizao Park, No. 6 Hengchuang Avenue, Zhongxin Town, Zengcheng District, Guangzhou, occupying the whole building, with offices and production at the same address. The ground floor holds the reception and the licence display area, where visits, sample deliveries and factory audits are handled.
From transducer assembly to final system release, all 102 models in production across 9 product categories are completed in this building. For the workshops, processes and inspection steps, see Manufacturing.
Where the four figures come from: 2011 is the date of establishment in the next section, Business and Entity Information (business registration); 102 is the actual count of models in production across the 9 categories of the product centre (42 handheld, 10 portable, 9 trolley, 7 veterinary, 4 ophthalmic, 2 bladder, 3 therapy, 14 ECG, 11 probes and accessories); 4 is the four registration certificates listed in the Licences and Permits section; 37 is the intellectual property table at the end of that section. Each of the four figures can be matched to a certificate or a page on this website.
Business and entity information
The details below are taken from the enterprise registration record and can be checked on the National Enterprise Credit Information Publicity System by unified social credit code; if the registered details change, the latest registration prevails.
| Company name | 广州索诺星信息科技有限公司 (Guangzhou Sonostar Information Technology Co., Ltd.) |
|---|---|
| Unified social credit code | 91440116574031770P |
| Entity type | Limited liability company (invested or controlled by natural persons) |
| Date of establishment | 16 May 2011 |
| Registered capital | RMB 10 million (paid-up RMB 10 million) |
| Term of operation | From 2011-05-16, with no fixed term |
| Registration authority | Guangzhou Huangpu District Administration for Market Regulation |
| Registration status | In existence (trading, open, on the register) |
| Registered address | Room 902, No. 6 Lianpu Street, Huangpu District, Guangzhou |
| Office and production address | Building 7, Zhongjiao Zhizao Park, No. 6 Hengchuang Avenue, Zhongxin Town, Zengcheng District, Guangzhou |
| Scope of business | Manufacture of medical diagnostic, monitoring and therapeutic equipment; manufacture of medical laboratory equipment and instruments; manufacture of mechanical therapeutic and ward nursing equipment; medical equipment leasing services; computer technology development and technical services; electronic product design services; import and export of technology; import and export of goods; wholesale trade in commodities (excluding goods subject to licensing or approval); retail trade in commodities (excluding goods subject to licensing or approval); commodity information consulting services; information technology consulting services. |
| Taxpayer status | General VAT taxpayer |
Note on addresses: the registered address in the table above is the registered domicile of the enterprise, and the business licence prevails; day-to-day offices and production are at Zhongjiao Zhizao Park in Zengcheng District, so for visits, sample deliveries and factory audits please use the office and production address.
Source: public enterprise registration information (latest approval date 2026-01-30), verified for this website on 2026-10-21. For licence and qualification numbers, see the next section, Licences and Permits.
Licences and permits
Each certificate and licence below can be checked by number on the relevant regulator's platform, and the originals can be viewed in Downloads › Certificates. The validity period stated on the certificate prevails.
Domestic production and operating licences
| Licence | Number | Coverage | Valid until |
|---|---|---|---|
| Medical device production licence Guangdong Provincial Medical Products Administration |
粤食药监械生产许20132454号 | Class II, 06 medical imaging equipment | 2028-05-07 |
| Medical device registration certificate Guangdong Provincial Medical Products Administration |
粤械注准20172060326 | Fully digital colour Doppler ultrasound diagnostic system Class II | 2031-09-23 |
| Medical device registration certificate Guangdong Provincial Medical Products Administration |
粤械注准20162061592 | Fully digital ultrasound imaging diagnostic instrument Class II | 2031-07-09 |
| Medical device registration certificate Guangdong Provincial Medical Products Administration |
粤械注准20162061593 | Fully digital ultrasound imaging diagnostic instrument Class II | 2031-07-07 |
| Medical device registration certificate Guangdong Provincial Medical Products Administration |
粤械注准20222060415 | Handheld colour Doppler ultrasound imaging instrument Class II | 2027-03-31 |
| Class II medical device trading record Guangzhou food and drug administration |
粤穗食药监械经营备20182027号 | Business mode: wholesale and retail | Record-based, no expiry date |
| Quality management system certification Zhongbing International Certification (Guangdong) Co., Ltd. |
91226Q00001R000 | GB/T 19001-2016 idt ISO 9001:2015; covering the design, manufacture and sale of handheld and portable ultrasound diagnostic instruments | 2029-01-11 |
| High-tech enterprise Guangdong Provincial Recognition Agency Office |
GR202444005315 | National high-tech enterprise | 2027-11-28 |
US FDA premarket notification (510(k))
| 510(k) number | Device name | Applicant |
|---|---|---|
| K171926 | C5 diagnostic ultrasound system | 广州索诺斯达科技有限公司 SonoStar affiliate |
| K172750 | Wireless probe-type ultrasound scanner (uprobe-C, uprobe-L, BProbe) | |
| K211321 | Wireless probe-type ultrasound scanner (CProbe, C/L/CT/CL types) |
Note: a 510(k) is a US premarket notification and means the notification procedure has been completed; it is not the same as FDA approval or certification. The applicant on the three records is a SonoStar affiliate rather than the entity operating this website, and is listed as recorded so that it can be verified.
Intellectual property (granted patents only)
| Patent type | Number | Main areas covered |
|---|---|---|
| Invention patents | 10 | Ultrasound imaging methods, ultrasound data processing and systems |
| Utility models | 7 | Probe structures, biopsy guides and complete-system structures |
| Design patents | 20 | Appearance of probe-type systems and accessories |
| Total valid grants | 37 | Patent certificates can be looked up by name in Downloads › Certificates |
Note: the table counts granted patents only and excludes terminated, withdrawn and still-pending applications. The number of grants changes with annuity payments and examination progress; the most recent verification prevails.
The earliest to expire of the registration certificates above is 粤械注准20222060415 (2027-03-31); renewal is filed in advance as required by the regulator. Validity periods on this page are updated as certificates change; last verified 2026-10-21.
Manufacturing capability
Where we manufacture, how much we can manufacture, and under which licence. This section gives verifiable facts only; for processes, quality inspection steps and factory visit arrangements, see the Manufacturing page.
| Production address | Building 7, Zhongjiao Zhizao Park, No. 6 Hengchuang Avenue, Zhongxin Town, Zengcheng District, Guangzhou — a stand-alone plant, with offices and production at the same address |
|---|---|
| Production licence | Medical device production licence 粤食药监械生产许20132454号, production scope Class II 06 medical imaging equipment, valid until 2028-05-07 |
| Core components | Ultrasound probes are made in-house; complete systems are assembled and calibrated in our own plant |
| Annual system capacity | about 10,000 units (normal capacity; actual output follows the production schedule and varies with configuration and order mix) |
| Minimum order quantity | From 1 unit; prototype and single-unit purchases are accepted equally |
| Factory audit | Visits to the plant and production lines can be arranged; please contact us in advance to confirm the time of your visit |
On-site data such as workshop floor area, number of production lines and headcount are not listed on this page and can be checked on site during a factory audit; lead times are answered in writing once confirmed against the current production schedule; the figures on this page are updated as actual capacity changes.
Manufacturing: plant, production lines and factory inspection
Product range
102 models in production, grouped into 9 categories by use rather than by price. The number of models on sale in each category follows the live data in the product centre.
| Category | Models | Main use |
|---|---|---|
| Handheld ultrasound scanners | 42 | The probe is the system, wireless to a phone or tablet; first choice for bedside and primary care |
| Portable ultrasound | 10 | Screen built into the body, carried in one hand; wards and medical vehicles |
| Trolley ultrasound | 9 | Large screen and multiple probe ports; routine examinations at a fixed station |
| Veterinary ultrasound | 7 | Fully waterproof body and long-handled rectal probe; pregnancy checks and backfat and loin measurement |
| Ophthalmic ultrasound | 4 | A-scan plus B-scan; morphological examination and IOL power measurement |
| Bladder ultrasound | 2 | BProbe wireless 4D; measurement of post-void residual bladder volume |
| Ultrasound therapy devices | 3 | Handheld therapy, drug delivery and electrolytic therapy |
| ECG monitors | 14 | ECG machines, multi-parameter monitors and fetal monitors |
| Ultrasound probes and accessories | 11 | Carts, wireless charging pads, biopsy guides, workstations and other accessories |
| Total | 102 | 9 categories covering diagnostic, monitoring and therapeutic uses |
Counts are of models currently on sale (verified 2026-10-22) and change as new products are launched and others discontinued; whether a given model is in production, its current configuration and probe compatibility are governed by the product page and by the reply to your enquiry. For the full classification see Products; for the clinical use of each model see Applications.
Export and overseas markets
Whether we can clear customs in our own name, and which documents a target market requires, are worth stating more clearly than how many countries we have sold to. This section lists only the parts that carry a number you can check.
| Export status | Registered with Customs as an importer and exporter of goods and able to clear customs in our own name, with no third-party export agent required; responsible customs office 穗东海关 (Suidong Customs) |
|---|---|
| Enterprise credit code | 91440116574031770P (the same code appears in the business registration, the NMPA certificates and the customs record, so it can be cross-checked) |
| US market | FDA 510(k) notifications obtained: 3 (K171926, K172750, K211321); numbers, devices and decision dates are in Licences and Permits |
| Other markets | Registration is handled country by country under the regulations in force in the destination country; the registration status and required documents for a given country are confirmed in writing at the quotation stage |
| Ways of working together | Distribution under our own brand, or ODM / OEM private labelling; for scope and process see Custom Development |
| Documents and logistics | Export documents are issued according to the destination country and the trade terms, and the list is confirmed order by order at the quotation stage; shipping method and port of arrival are agreed with each order |
How to verify
The customs record can be checked on the China Customs Enterprise Credit Information Publicity Platform (credit.customs.gov.cn) by entering the company name or the unified social credit code; overseas market access can be checked by the routes in the table below.
| Market | What to check | Where to check |
|---|---|---|
| United States | 510(k) number and decision date | FDA 510(k) Premarket Notification Database (route given in Four verification routes) |
| China (exporter side) | Importer and exporter registration | China Customs Enterprise Credit Information Publicity Platform |
| Other countries | Registration certificate or import licence | Issued by the regulator in the destination country; confirmed per order where we are asked to provide it |
Note: this section does not give totals such as the number of countries sold to — such figures have no public source that can be checked, and stating them would cast doubt on the other figures. To discuss specific markets and projects, please contact the overseas sales department.
Overseas business contact
Export, registration and overseas agency matters are handled by the overseas sales department at sonostar168@163.com; when you enquire, please also state the destination country, quantity and whether destination-country registration documents are required, and we will prepare the documents to match.
Four verification routes
This section does not ask you to take any statement on this page on trust; it only tells you where to look, what to enter and what you should see. All four platforms are maintained by regulators, and all are free and need no registration.
| What to verify | Where to look | What to enter | What you should see |
|---|---|---|---|
|
Medical device registration certificate
4 in total, all Class II |
NMPA Data Search › Medical Devices nmpa.gov.cn/datasearch The Guangdong MPA data search draws on the same source; either one will find it |
The registration certificate number, e.g. 粤械注准20172060326
Or just the last 11 digits, 20172060326 |
Registrant 广州索诺星信息科技有限公司; product name 全数字彩色多普勒超声诊断系统 (fully digital colour Doppler ultrasound diagnostic system); valid until 2031-09-23 |
|
Medical device production licence
1 in total |
Guangdong Provincial Medical Products Administration, Data Search mpa.gd.gov.cn |
粤食药监械生产许20132454号
Or search by company name |
Company name 广州索诺星信息科技有限公司; production scope Class II 06 medical imaging equipment; valid until 2028-05-07 |
| ISO 9001 quality management system certification | National Certification and Accreditation Information Public Service Platform (CNCA) cx.cnca.cn |
Certificate number 91226Q00001R000 | Certification basis GB/T 19001-2016 idt ISO 9001:2015; scope: design, manufacture and sale of handheld and portable ultrasound diagnostic instruments; valid until 2029-01-11 |
|
US FDA 510(k)
3 in total |
US FDA 510(k) Premarket Notification Database accessdata.fda.gov |
K171926, K172750, K211321 | Applicant "Guangzhou Sonostar Technologies Co., Ltd."; Decision "Substantially Equivalent"; Decision Dates in order 2017-10-27, 2018-02-28, 2022-10-13 |
How to check the business registration
The full company name, unified social credit code, date of establishment and registered capital in the Business and Entity Information section of this page can be checked on the National Enterprise Credit Information Publicity System (gsxt.gov.cn) by entering the unified social credit code 91440116574031770P; this is separate from the four routes above.
If you cannot find a record, it is usually one of these four cases
-
The number was mistyped. In a registration certificate number, 粤械注准 is a prefix and the body of the number is 11 digits, so getting one digit wrong returns nothing; the same applies to the prefix 粤食药监械生产许 in the production licence number.
-
Looking up a domestic certificate with the English name. The applicant on the FDA records is Guangzhou Sonostar Technologies Co., Ltd., which is not the same written name as 广州索诺星信息科技有限公司 on the domestic certificates; the two systems are searched separately, so do not mix them.
-
The platform is under maintenance. The NMPA and CNCA search systems may be unavailable or time out outside working hours; try again during working hours.
-
The data lags behind. If a platform record differs from this page, the platform record and the original certificate prevail; you are also welcome to tell us so that we can correct it, and we will update this page once verified.
Note: a 510(k) is a US premarket notification procedure, and a Decision of "Substantially Equivalent" means the device has been found substantially equivalent to a legally marketed device; it is not the same as FDA approval or certification. The applicant on the three records is a SonoStar affiliate rather than the entity operating this website, and is listed as recorded so that it can be verified.
Related pages and contact
This page answers only who we are and which certificates we hold. To see how we manufacture, whether we can customize and which models exist, follow the table below.
| What you want to check | Which page to go to |
|---|---|
| Company identity, registered capital, registered address | The Business and Entity Information section of this page |
| Numbers and validity periods of registration certificates, production licence, ISO and FDA | The Licences and Permits section of this page; the original certificates are in Downloads › Certificates |
| How the workshops run, how products are inspected, whether you can visit the plant | Manufacturing: plant, production lines, processes and factory inspection |
| Whether we offer private labelling, and whether appearance and software can be changed | Custom Development: ODM / OEM scope, process and packages |
| Model range, specifications and compatible probes | Products: 102 models across 9 categories; for specification comparisons see Selection Guide |
| Manuals, software and selection tables for download | Downloads: certificates, software and selection materials |
| Quotations, lead times, distribution and after-sales | See the contact details below, or send us an enquiry |
Contact us
| Address | Building 7, Zhongjiao Zhizao Park, No. 6 Hengchuang Avenue, Zhongxin Town, Zengcheng District, Guangzhou (offices and production at the same address; please use this address for visits and sample deliveries) |
|---|---|
| Phone | +86 13434822215 (Mr. Zhong, same number on WhatsApp) |
| sonostar168@163.com | |
| Working hours | Mon-Fri 9:00-22:00, Sat 9:00-18:00(Beijing Time, GMT+8) |
Stating the intended use, quantity and whether customization or destination-country registration documents are needed when you enquire can save a round of correspondence. Entry points for verifying licences and registrations are collected in the Four verification routes section.
