This company holds 33 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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 2026-09-03. 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20253211392 | 胶囊内窥镜辅助阅片软件 | Class III |
| CN | 国械注准20253060810 | 胶囊式内窥镜系统 | Class III |
| CN | 国械注准20213060727 | 磁控胶囊式内窥镜系统 | Class III |
| CN | 国械注准20203060734 | 胶囊式胃内窥镜系统 | Class III |
| UK | 15137 | Data Recorder | Class IIa |
| UK | 41617 | Endoscopic Carbon Dioxide Regulation Units | Class IIa |
| UK | 62242 | Colorectal Manometry Catheter | Class IIa |
| US | K210618 | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series | 2021-10-20 |
| US | K172151 | Hysteroscopy System | 2018-04-09 |
| BR | 80117589140 | Endoscope Video Processor | Class II |
| BR | 80117589141 | Video Colonoscope | Class II |
| BR | 80117589142 | Video Gastroscope | Class II |
| CA | 86038 | OMOM CAPSULE GASTROINTESTINAL ENDOSCOPY SYSTEMS | Class II |
| CA | 92088 | OMOM CONTROLLABLE STOMACH CAPSULE SYSTEM | Class II |
| CA | 97618 | JSX-1 HYSTEROSCOPY SYSTEM | Class II |