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Cardiopulmonary resuscitation machine - NMPA Registration 粤械注准20242081631

Access comprehensive regulatory information for Cardiopulmonary resuscitation machine 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20242081631 and owned by Shenzhen Comen Medical Instruments Co., Ltd.. The device was approved on December 10, 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.

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NMPA Official Data
Class II
粤械注准20242081631
Cardiopulmonary resuscitation machine
心肺复苏机
NMPA Registration Number: 粤械注准20242081631
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Pricing
Intended Use
English

心肺复苏机用于对出现急性心脏骤停(即:失去自主呼吸与脉搏跳动以及失去知觉)的成年患者进行胸外心脏按压.

中文

心肺复苏机用于对出现急性心脏骤停(即:失去自主呼吸与脉搏跳动以及失去知觉)的成年患者进行胸外心脏按压。

Device Classification
Device Class
Class II
Model Specifications
ES3、ES3A、ES3B、ES5、ES5A、ES5B
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242081631
Approval Date
December 10, 2024
Expiry Date
December 09, 2029
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

由主机(含上装部分、背板、稳定带、固定带等)、电池、电源适配器、充电器及二氧化碳附件组成.

中文

由主机(含上装部分、背板、稳定带、固定带等)、电池、电源适配器、充电器及二氧化碳附件组成。

Additional Information
Remark
本文件与“粤械注准20242081631”注册证共同使用。
Changes
2024-12-17: 1、生产地址由“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”变更为“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 ”。