China NMPA legacy archive 粤械注准20252180051Obstetric special monitor
产科专用监护仪
Shenzhen Comen Medical Instruments Co., Ltd.Class IINMPAApproved January 15, 2025
Static archiveNMPA · legacy registration snapshot
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
- Province/Region
- Guangdong
- 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
广东
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
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。
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。
About this record
This static archive preserves historical registration fields and translations for Obstetric special monitor, registration 粤械注准20252180051. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.