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Portable color Doppler ultrasound diagnostic instrument - NMPA Registration 粤械注准20252060041

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.

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NMPA Official Data
Class II
粤械注准20252060041
Portable color Doppler ultrasound diagnostic instrument
便携式彩色多普勒超声诊断仪
NMPA Registration Number: 粤械注准20252060041
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Pricing
Intended Use
English

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。

Device Classification
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 Information
Registration Number
粤械注准20252060041
Approval Date
January 13, 2025
Expiry Date
January 12, 2030
Registrant
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 Facility
Production Address
深圳市光明新区南环大道1203号
Structure and Composition
English

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。

Additional Information
Appendix
产品技术要求