This company holds 44 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥87, 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 2026-09-02. 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20263100072 | 一次性使用心脏停跳液灌注器 | Class III |
| CN | 国械注准20263071378 | 一次性使用有创血压传感器 | Class III |
| CN | 国械注准20253131764 | 聚醚醚酮胸骨固定带 | Class III |
| CN | 国械注准20253130036 | 颅骨修复系统 | Class III |
| EU | 06944803606035 | — | Class IIa |
| EU | 06944803672863 | — | Class IIa |
| EU | 06944803672856 | — | Class IIa |
| EU | 06944803606011 | — | Class IIa |
| UK | 64275 | MAXine System | Class I |
| US | K223875 | MOBINEURO Alita Intraoperative MRI System | 2023-03-20 |
| US | K190767 | AnatomicAligner | 2020-03-16 |
| US | K130569 | ND NABIL DIB INFUSION CATHETER | 2013-11-15 |
| BR | 81387399003 | Sistema de Cardioplegia Cristaloide | Class II |
| BR | 81387399004 | Conjunto Descartável Estéril para Circulação Extracorpórea PRÉMONTADO | Class II |
| BR | 81387399005 | Sistema de Cardioplegia Sanguínea 4:1 | Class II |
| SA | ME0000004167SFDAA00020 | Gammaprobe Surgical Explorer | — |