This company holds 6 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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20263021399 | 一次性使用腔镜用直线型切割吻合器及组件 | Class III |
| CN | 国械注准20263011423 | 超声软组织手术设备 | Class III |
| CN | 国械注准20263011175 | 一次性使用电动直线型切割吻合器及钉仓组件 | Class III |
| CN | 国械注准20253010503 | 超声高频外科集成手术设备 | Class III |
| EU | 06973573410399 | Connector | Class I |
| UK | 11490 | Radiofrequency and Ultrasonic Surgical Generator | Class IIb |
| UK | 11490 | Portable Radiofrequency Surgical Generator | Class IIb |
| UK | 57944 | SanPulse Tissue Sealer/Divider Curved | Class IIb |
| US | K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45) | 2025-06-18 |