This company holds 12 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Hong Kong — 4 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 | 皖械注准20252060025 | 灌注吸引系统 | Class II |
| CN | 皖械注准20242060229 | 一次性使用输尿管内窥镜导管 | Class II |
| CN | 皖械注准20242020073 | 一次性使用输尿管导引鞘 | Class II |
| CN | 皖械注准20232060071 | 一次性使用术中测压输尿管内窥镜导管 | Class II |
| EU | 06972498493487 | Renal Pressure Monitoring Processor | Class I |
| EU | 06972498493548 | Single Use Digital Flexible Ureteroscope w/ Pressure Monitoring | Class IIa |
| EU | 06972498493531 | Single Use Digital Flexible Ureteroscope w/ Pressure Monitoring | Class IIa |
| EU | 06972498493524 | Single Use Digital Flexible Ureteroscope w/ Pressure Monitoring | Class IIa |
| UK | 18034 | Renal Pressure Monitoring Processor | Class I |
| UK | 18034 | Videoscope Imaging Processor | Class IIa |
| UK | 64074 | Single Use Digital Flexible Ureteroscope (7.5F) | Class IIa |
| US | K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) | 2026-04-09 |
| US | K250128 | Single Use Suction-Evacuation Ureteral Access Sheath | 2025-09-19 |