Quality Management: How Every Unit Is Built and Released
Every SonoStar ultrasound system is assembled, tuned and released in one building in Zengcheng, Guangzhou. This page sets out what the manufacturing licence covers, the five process steps, the three inspection gates, and the certificates behind them — each with a number you can look up yourself.
The manufacturing licence sets the boundary
Four characters on a Chinese manufacturing licence — the scope of production — decide what a factory is permitted to build and what it is not. Ours reads Class II, category 06: medical imaging equipment. Diagnostic ultrasound sits inside that category.
| Item | Detail |
|---|---|
| Licence | Medical Device Manufacturing Licence |
| Number | 粤食药监械生产许20132454号 |
| Issued by | Guangdong Provincial Medical Products Administration |
| Scope | Class II, category 06 — medical imaging equipment |
| Valid until | 2028-05-07 |
| Manufacturing site | Building 7, Zhongjiao Zhizao Park, Hengchuang Avenue 6, Zhongxin Town, Zengcheng District, Guangzhou — a single building used for both office and production |
| Products covered | Four Class II registration certificates, covering colour Doppler ultrasound diagnostic systems, ultrasound imaging diagnostic instruments and handheld colour Doppler instruments |
All four registration certificates and the manufacturing licence can be checked on the National Medical Products Administration database and the Guangdong provincial database. The exact search terms and the expected result are listed under Where to check below.
Five steps, and the specific failure each one prevents
Material comes in at one end and a packed unit leaves at the other, without the flow doubling back. Each step exists to catch a named kind of defect at the point where it is still catchable.
Incoming inspection
Components, structural parts and cables are checked on arrival — model, batch and appearance — and rejected material is returned. Prevents: bad material entering the line and only surfacing at final test.
Probe and unit assembly
Probe element assembly and harness soldering, then mainboard and structural assembly. Prevents: cold joints, wrong parts and assembly stress — none of which are visible on a finished unit.
Tuning and burn-in
Power-on tuning, image and measurement calibration, then continuous powered burn-in. Prevents: early-life failures reaching the customer and failing after two weeks of use.
Release inspection
Item-by-item inspection against the product technical requirements attached to the registration certificate, with a per-unit record and signature. Prevents: a non-conforming unit leaving the factory.
Packing and warehousing
Main unit, probe, accessories and accompanying documents are matched by model, then packed with shock protection and stored. Prevents: transport damage and wrong-model shipments.
Probes are not outsourced. Piezoelectric element assembly and harness soldering are completed in our own workshop, and every probe is then imaged on a unit before it is matched to a system. Building probe and host under one roof means a problem between the two never becomes an argument between two suppliers.
Inspection is not a final gate, it is a line running the whole way
Five things have to be defined before an inspection means anything: the basis, the person responsible, the moment it happens, the record it leaves, and the condition for release.
| Element | How it is defined |
|---|---|
| Basis | The product technical requirements attached to each registration certificate. Every certificate has its own document, and the test items and pass criteria are written into it. |
| Responsibility | The quality inspection post is organisationally separate from the assembly post. Results are signed for by the inspector who performed them. |
| Timing | Three fixed points: material arriving, assembly completed, unit leaving the factory. Each point is inspected once, not sampled away. |
| Records | Recorded per unit and archived per batch, traceable by model and batch number. |
| Release | Only after every test item passes is a unit packed and warehoused. A failed unit is repaired and re-inspected — it does not skip the queue. |
Test items are executed item by item against the registration document and filed per unit. If you need the test list for a specific model, ask for it during a factory visit or at the quotation stage and we will provide it for that model.
What sits behind the quality claim
Six documents, all with a number and an expiry date. Scanned originals are downloadable from the certificates page; nothing here is stated without a document behind it.
| Document | Number | Scope | Valid until |
|---|---|---|---|
| Medical device registration certificate Guangdong Provincial MPA |
粤械注准20172060326 | Full digital colour Doppler ultrasound diagnostic system — Class II | 2031-09-23 |
| Medical device registration certificate Guangdong Provincial MPA |
粤械注准20162061592 | Full digital ultrasound imaging diagnostic instrument — Class II | 2031-07-09 |
| Medical device registration certificate Guangdong Provincial MPA |
粤械注准20162061593 | Full digital ultrasound imaging diagnostic instrument — Class II | 2031-07-07 |
| Medical device registration certificate Guangdong Provincial MPA |
粤械注准20222060415 | Handheld colour Doppler ultrasound imaging instrument — Class II | 2027-03-31 |
| Quality management system certification Zhongbing International Certification (Guangdong) |
91226Q00001R000 | GB/T 19001-2016 idt ISO 9001:2015 — design, manufacture and sale of handheld and portable ultrasound diagnostic instruments | 2029-01-11 |
| National High-Tech Enterprise Guangdong provincial recognition office |
GR202444005315 | National high-tech enterprise status | 2027-11-28 |
The earliest expiry among the four registration certificates is 粤械注准20222060415 (2027-03-31); renewal is filed ahead of the deadline as required. This table follows the certificates — last verified 2026-10-21.
Three FDA 510(k) clearances — and what they do not mean
A 510(k) is a premarket notification. A decision of Substantially Equivalent means the device was found equivalent to one already legally marketed. It is not an FDA approval, and it is not a certification of the factory.
| 510(k) number | Device | Decision date | Applicant |
|---|---|---|---|
| K171926 | C5 diagnostic ultrasound system | 2017-10-27 | Guangzhou Sonostar Technologies Co., Ltd. Affiliated company, not the site operator |
| K172750 | Wireless probe ultrasound scanner (uprobe-C, uprobe-L, BProbe) | 2018-02-28 | |
| K211321 | Wireless probe ultrasound scanner (CProbe, C/L/CT/CL) | 2022-10-13 |
Note on the applicant: these three records name SonoStar's affiliated company, not the entity operating this website. We list them as they appear in the FDA database so they can be checked without a detour through us. For any market outside China and the United States, registration is handled country by country under the regulations in force there, and the status for a given country is confirmed in writing at quotation.
Where to check, what to type, what you should see
None of this page asks to be taken on trust. All four platforms below are run by regulators, free to use and require no account.
| What | Where | Type this | You should see |
|---|---|---|---|
| Registration certificate Four, all Class II |
NMPA database, Medical Devices section nmpa.gov.cn/datasearch The Guangdong provincial database mirrors it; both return the record |
粤械注准20172060326 The 11 trailing digits also work |
Registrant: Guangzhou Sonostar Information Technology Co., Ltd. (shown on the database as 广州索诺星信息科技有限公司); product: full digital colour Doppler ultrasound diagnostic system; valid until 2031-09-23 |
| Manufacturing licence One |
Guangdong Provincial MPA, Data Query mpa.gd.gov.cn |
粤食药监械生产许20132454号 Or search the company name |
Scope Class II, category 06 — medical imaging equipment; valid until 2028-05-07 |
| ISO 9001 certificate | National Certification and Accreditation Information Service cx.cnca.cn |
91226Q00001R000 | Basis GB/T 19001-2016 idt ISO 9001:2015; scope covers design, manufacture and sale of handheld and portable ultrasound diagnostic instruments; valid until 2029-01-11 |
| FDA 510(k) Three records |
FDA 510(k) Premarket Notification Database accessdata.fda.gov |
K171926, K172750, K211321 | Applicant Guangzhou Sonostar Technologies Co., Ltd.; decision Substantially Equivalent; decision dates 2017-10-27, 2018-02-28 and 2022-10-13 |
If a search returns nothing
- The number was mistyped. In a registration number the Chinese prefix is not part of the search key — the body is 11 digits, and one wrong digit returns an empty result. Same for the manufacturing licence.
- An English name was used against a Chinese record. The FDA record names Guangzhou Sonostar Technologies Co., Ltd.; the Chinese licences name Guangzhou Sonostar Information Technology Co., Ltd. They are different strings in different systems — search each system with its own.
- The platform is down. The drug administration and certification platforms can time out outside Chinese business hours. Try again on a weekday.
- The platform lags. Where a platform record differs from this page, the platform and the certificate original take precedence. Tell us and we will correct this page after verifying.
Two ways to verify further
A certificate proves a system exists. It does not show you the line it runs on. For that, the fastest route is the workshop.
Manufacturing: the line behind the certificates
Workshop layout, the four work areas, in-house probe production and how to book a factory visit.
View page →Book a visit or request documents
Tell us the model and the market, and we will send the matching test list, certificate scans and a factory visit slot.
Contact us →
