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Vital signs monitors - NMPA Registration 粤械注准20252070174

Access comprehensive regulatory information for Vital signs monitors 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20252070174 and owned by Shenzhen Comen Medical Instruments Co., Ltd.. The device was approved on February 05, 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20252070174
Vital signs monitors
生命体征监测仪
NMPA Registration Number: 粤械注准20252070174
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Pricing
Intended Use
English

监测仪适用于医疗机构对成人、小儿和新生儿进行无创血压(NIBP)、脉搏氧饱和度(SPO2)、脉率(PR)、体温(Temp)、二氧化碳(CO2)的监测。监测信息可以显示、回顾、存储和打印。

Device Classification
Device Class
Class II
Model Specifications
NC6D、NC6E、NC6F、NC6N、NC7D、NC7E、NC7F、NC7N
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20252070174
Approval Date
February 05, 2025
Expiry Date
February 04, 2030
Registrant
Name
Shenzhen Comen Medical Instruments Co., Ltd.
深圳市科曼医疗设备有限公司
Province/Region
Guangdong
广东
Address
Building 1, A10-11 Floor, 12C, Building 1, FIYTA Watch Building, South Ring Avenue, Mashantou Community, Matian Street, Guangming District, Shenzhen, Building 2, 1-5 Floors (one license with multiple addresses)
深圳市光明区马田街道马山头社区南环大道飞亚达钟表大厦 1 栋 A10 层-11 层、12C,2 栋 1-5 层(一照多址企业)
Production Facility
Production Address
深圳市光明区马田街道南环大道飞亚达钟表大厦2栋1-5层; 深圳市光明区马田街道富利南路与芳园路交汇处瑞辉大厦3、8楼,4楼北侧; 东莞市黄江镇星光辰星路2号冠城三良产业园(区)9栋(A单元)3楼-4楼
Structure and Composition
English

监测仪由主机、扩充基座(可选配)和无创血压袖带附件、脉搏血氧饱和度附件、呼吸末二氧化碳附件(可选配)和体温附件(可选配)组成。

Additional Information
Appendix
产品技术要求