This company holds 21 NMPA certificates in China and has registrations in European Union, United States, Brazil, South Korea, Israel, Russia — 6 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20253031630 | 亲水涂层造影导管 | Class III |
| CN | 国械注准20253031006 | 外周血栓抽吸导管 | Class III |
| CN | 国械注准20253030336 | 血管造影导管 | Class III |
| CN | 国械注准20253030181 | 外周血栓抽吸导管 | Class III |
| EU | 06970226520726 | Navajo | Class IIa |
| EU | 06970226520719 | Navajo | Class IIa |
| EU | 06970226520702 | Navajo | Class IIa |
| EU | 06970226520696 | Navajo | Class IIa |
| US | K220604 | EXTesia Introducer Sheath Set | 2022-04-27 |
| US | K180797 | Xcess Guiding Catheter | 2018-12-14 |
| US | K171290 | Vela RX PTA Balloon Dilatation Catheter | 2017-07-19 |
| BR | 81231550012 | Cateter Guia Curatia. | Class II |
| BR | 81231550013 | Cateter Balão para Dilatação. | Class II |
| BR | 81231550014 | Cateter Angiográfico URSA | Class II |