Patient monitors
- Device class
- Class III
- Model specifications
- RespArray
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243072341
- Approval date
- November 21, 2024
- Expiry date
- November 20, 2029
- Name
- Edan Instruments, Inc.深圳市理邦精密仪器股份有限公司
- Province/Region
- Guangdong广东
- Address
- No. 15, Jinhui Road, Jinsha Community, Kengzi Street, Pingshan New District, Shenzhen深圳市坪山新区坑梓街道金沙社区金辉路15号
- Production address
- 深圳市坪山新区坑梓街道金沙社区金辉路15号
产品在医疗机构中使用,用于对成人、小儿和新生儿进行心电(含ST段测量,QT/QTc测量和心律失常分析,其中心律失常分析不用于小儿和新生儿)、呼吸、体温、脉搏血氧饱和度、无创血压、呼气末二氧化碳的监护.
产品在医疗机构中使用，用于对成人、小儿和新生儿进行心电（含ST段测量，QT/QTc测量和心律失常分析，其中心律失常分析不用于小儿和新生儿）、呼吸、体温、脉搏血氧饱和度、无创血压、呼气末二氧化碳的监护。
产品由主机和功能附件组成,详见附页.
产品由主机和功能附件组成，详见附页。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Patient monitors in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243072341 and owned by Edan Instruments, Inc.. The device was approved on November 21, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.