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Medical temperature controller - NMPA Registration 粤械注准20242091401

Access comprehensive regulatory information for Medical temperature controller 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20242091401 and owned by Shenzhen Comen Medical Instruments Co., Ltd.. The device was approved on October 24, 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20242091401
Medical temperature controller
医用控温仪
NMPA Registration Number: 粤械注准20242091401
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DJ Fang

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Pricing
Intended Use
English

In the clinical use environment of medical institutions, the temperature of the application part is controlled to achieve the function of external physical heating and/or cooling of the human body in vitro to achieve the purpose of assisting in regulating the temperature of the human body.

中文

在医疗机构临床使用环境下,通过控制应用部分的温度实现对人体进行体外物理升温和/或降温功能,以达到辅助调节人体温度的目的。

Device Classification
Device Class
Class II
Model Specifications
P2、P2A、P2B、P2C
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242091401
Approval Date
October 24, 2024
Expiry Date
October 23, 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第七工业区108B栋二楼;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、水毯、水毯套(选配)和温度探头组成.

中文

由主机、水毯、水毯套(选配)和温度探头组成。

Additional Information
Remark
本文件与“粤械注准20242091401”注册证共同使用。
Changes
2024-11-01: 1、注册人住所由“深圳市光明区马田街道马山头社区钟表基地飞亚达钟表大厦 2 栋 101(一照多址企业)”变更为“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)”。 2、生产地址由“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 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)3-4楼”变更为“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第七工业区108B栋二楼;深圳市光明街道高新西路11号研祥科技工业园机械厂房(创祥地2号)五楼西侧单元501、502;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;东莞市黄江镇星光辰星路2号冠城三良产业园(区)9栋(A单元)3楼-4楼;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”。 2024-12-17: 1、生产地址由“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第七工业区108B栋二楼;深圳市光明街道高新西路11号研祥科技工业园机械厂房(创祥地2号)五楼西侧单元501、502;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;东莞市黄江镇星光辰星路2号冠城三良产业园(区)9栋(A单元)3楼-4楼;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”变更为“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第七工业区108B栋二楼;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”。