This company holds 1 NMPA certificates in China and has registrations in United States, Brazil, South Korea, Hong Kong, Israel — 5 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 | 苏械注准20172141845 | 一次性使用无菌压力泵 | Class II |
| US | K231402 | HP PTA Balloon Dilatation Catheter | 2023-12-20 |
| US | K221245 | PTA Balloon Dilatation Catheter | 2022-12-14 |
| US | K211349 | Selebrek PTCA Balloon Dilatation Catheter | 2022-01-07 |
| BR | 82195309002 | Cateter Balão para Dilatação HP PTA OTW 0,0350 | Class II |
| BR | 82195309012 | Cateter de Dilatação com Balão PTA | Class II |