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Obstetric special monitor - NMPA Registration 粤械注准20252180051

Access comprehensive regulatory information for Obstetric special monitor 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20252180051 and owned by Shenzhen Comen Medical Instruments Co., Ltd.. The device was approved on January 15, 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20252180051
Obstetric special monitor
产科专用监护仪
NMPA Registration Number: 粤械注准20252180051
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Pricing
Intended Use
English

本产品适用于医院对母亲的心电、心率、脉搏血氧饱和度、脉率、呼吸、体温、宫缩压力以及胎儿的胎心率、胎动进行监测。

Device Classification
Device Class
Class II
Model Specifications
CF5、CF5A、CF50、CF50A、CF5 R、CF5A R、CF50 R、CF50 A R、CF8、CF8A、CF80、CF80A、CF8 R、CF8A R、CF80 R、CF80 A R
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20252180051
Approval Date
January 15, 2025
Expiry Date
January 14, 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
A10-11 floors, 12C, 2 buildings, 1-5 floors, Building 1, FIYTA Watch Building, South Ring Avenue, Mashantou Community, Matian Street, Guangming District, Shenzhen
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富利南路与芳园路交汇处瑞辉大厦3、8楼,4楼北侧;深圳市光明区马田街道马山头社区钟表基地君斯达科技园D栋第3层和第4层;深圳市光明区玉塘街道田寮社区先能路86号301、302;东莞市黄江镇辰星路2号冠城三良智慧工业园一号厂房A单元3楼-4楼、B单元302;深圳市光明区马田街道合水口社区第四工业区第四期第二栋(原名恒寿科技园)3号厂房第1-4层
Structure and Composition
English

产品由主机(含电池、支架、显示屏、记录仪、外壳)和相应的功能附件(心电电缆、血氧传感器、体温探头、胎心率探头、宫缩压探头、打标器、胎儿唤醒器)组成。

Additional Information
Remark
本文件与“粤械注准20252180051”注册证共同使用。