This company holds 37 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets.
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.
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 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| CN | 国械注准20243061709 | 经食管超声探头 | Class III |
| CN | 国械注准20233061835 | 超声探头 | Class III |
| CN | 国械注准20233060164 | 彩色多普勒超声诊断仪 | Class III |
| CN | 粤械注准20252061436 | 全数字彩色多普勒超声诊断系统 | Class II |
| EU | 06938396497064 | — | Class I |
| EU | 06938396497033 | — | Class I |
| EU | 06938396497040 | — | Class I |
| EU | 06938396497026 | — | Class I |
| US | K210317 | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System | 2021-08-19 |
| US | K210318 | Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System | 2021-08-18 |
| US | K202350 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System | 2021-01-06 |