Portable color Doppler ultrasound diagnostic instrument
- Device class
- Class II
- Model specifications
- MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MX6P, MX6Q, MX6W, MXG, Emerus MX6, Emerus MX6S, Emerus MX6 Exp, Anesus MX6, Anesus MX6S, Anesus MX6 Exp, Crius MX6, Crius MX6S, Crius MX6 Exp, MX GA, MX GT, MX GN, MX5E, MX EA, MX EB, MX EC
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20252060041
- Approval date
- January 13, 2025
- Expiry date
- January 12, 2030
- Name
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.深圳迈瑞生物医疗电子股份有限公司
- Province/Region
- Guangdong广东
- Address
- Floor 1-4, Mindray Building, Keji South 12th Road, High-tech Industrial Park, Nanshan District, Shenzhen深圳市南山区高新技术产业园区科技南十二路迈瑞大厦1-4层
- Production address
- 深圳市光明新区南环大道1203号
在医疗机构中，用于临床超声诊断检查，各探头临床应用见产品技术要求附录B。
诊断仪由主机和探头组成。 可选配的超声探头型号为：C6-1m、C5-1m、C5-2m、C5-2m-e、D7-2m、D6-2m、L14-3m、L13-3m、L12-3m、L12-3m-e、L14-3Ws、L12-3Wm、L18-6m、HS14-5Lm、7LT4s、L9-3m、SP5-1m、P4-2m、P8-2m、P10-4m、V11-3m、V11-3m-B、V10-4m、V10-4m-B、V11-3Hs、CB10-4s、ELC13-4s、CW2s、CW5s、mC5-2m、mC11-3m、C9-3Ts、SC6-1s； 可选配的穿刺架型号为：NGB-004、NGB-007、NGB-010、NGB-011、NGB-022、NGB-025、NGB-034、NGB-045、NGB-051、NGB-054、NGB-055、NGB-018、NGB-003； 可选配的硬件选配件为：台车（MT3A/ MT3/ MT1）、探头适配器、脚踏开关、ECG模块。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Portable color Doppler ultrasound diagnostic instrument in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252060041 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was approved on January 13, 2025.
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.