This company holds 28 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, Hong Kong, Israel — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.
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 2026-09-03. 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20263011814 | 一次性使用微波消融导管 | Class III |
| CN | 国械注准20263011602 | 一次性使用微波消融针 | Class III |
| CN | 国械注准20263010936 | 一次性使用静脉腔内射频闭合导管 | Class III |
| CN | 国械注准20253132338 | 聚乙烯醇栓塞微球 | Class III |
| EU | 06954414684704 | Endovenous Radiofrequency Ablation Catheter | Class IIb |
| EU | 06954414684698 | Endovenous Radiofrequency Ablation Catheter | Class IIb |
| EU | 06954414684681 | Endovenous Radiofrequency Ablation Catheter | Class IIb |
| EU | 06954414684674 | Endovenous Radiofrequency Ablation Catheter | Class IIb |
| UK | 61287 | Canyon | Class IIb |
| UK | 61286 | Microwave Ablation Antenna | Class IIb |
| UK | 58990 | Disposable Biopsy Needle, Coaxial Biopsy Needle | Class IIa |
| US | K250209 | Polyvinyl Alcohol Embolic Microspheres | 2025-09-23 |
| US | K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | 2024-09-26 |
| US | K241825 | Microwave Ablation Antennas | 2024-09-20 |
| BR | 81504799259 | Agulha de Biópsia Coaxial | Class II |
| BR | 81504799262 | Agulha de Biópsia Descartável Automática | Class II |
| BR | 81504799263 | Agulha de Biópsia Descartável Semiautomática | Class II |