This company holds 26 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets. EU UDI-DI records ≥27, 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| CN | 国械注准20263141648 | 胰岛素泵 | Class III |
| CN | 国械注准20263141406 | 胰岛素泵用皮下输液器 | Class III |
| CN | 国械注准20263071832 | 持续葡萄糖监测系统 | Class III |
| CN | 国械注准20253142625 | 胰岛素泵用储药器组件 | Class III |
| EU | 06958590315834 | LinX10 | Class IIb |
| EU | 06958590303985 | WELLION | Class IIb |
| EU | 06958590307617 | WELLION | Class IIb |
| EU | 06958590306177 | WELLION | Class IIb |
| UK | 63262 | Insulin Infusion Sets | Class IIa |
| UK | 35838 | Insulin Infusion Pump Reservoirs | Class IIb |
| UK | 51083 | Ambulatory Insulin Infusion Pumps | Class IIb |
| US | K193340 | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System | 2020-09-11 |
| BR | 80560310103 | PANCARES | Class I |