This company holds 4 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Australia, Israel, Russia — 9 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 KRX KIND, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| CN | 苏械注准20242062027 | 数字化乳腺X射线机 | Class II |
| CN | 苏械注准20202061139 | 数字化X射线成像系统 | Class II |
| CN | 苏械注准20202060881 | 数字化X射线成像系统 | Class II |
| CN | 苏械注准20202060834 | 数字化X射线成像系统 | Class II |
| EU | 08800018421505 | EXSYS DEXi | Class IIb |
| EU | 08800018421604 | EXSYS DEXi | Class IIb |
| EU | 08800018421703 | EXSYS DEXi | Class IIb |
| EU | 08800018421802 | EXSYS DEXi | Class IIb |
| UK | 37646 | Mobile Fluoroscopic X-ray System | Class IIa |
| US | K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | 2025-06-10 |
| US | K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | 2025-03-20 |
| US | K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | 2025-03-19 |
| BR | 80117580654 | Solução de Radiografia de Painel Plano | Class II |
| BR | 80117589086 | Solução de Radiografia de Painel Plano | Class II |
| BR | 80117580432 | Solução de Radiografia de Painel Plano | Class I |